A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

Start Date01 Jan 2030

Sponsor / Collaborator

Lisata Therapeutics, Inc.

NCT04910386

/ Not yet recruitingPhase 2

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

Start Date01 Jun 2027

Sponsor / Collaborator

3D Medicines (Sichuan) Co., Ltd.

NCT07492680

/ Not yet recruitingPhase 2

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.

Start Date17 Jul 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

14,590

Literatures (Medical) associated with Gemcitabine Hydrochloride

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

Author: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Lotan, Yair ; Zhao, Angela

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

01 Mar 2026·JOURNAL OF CLINICAL ONCOLOGY

Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results

Article

Author: Sanchez de Llano, Cristina ; Necchi, Andrea ; Crispen, Paul L. ; Szabados, Bernadett ; Hasan, Mohamad ; Psutka, Sarah P. ; Battaglia, Sebastiano ; Peyton, Charles C. ; Bögemann, Martin ; Stitou, Hind ; Shore, Neal ; Preston, Mark A. ; Pradere, Benjamin ; Gong, Cinty ; Ku, Ja Hyeon ; Guerrero-Ramos, Félix ; Garje, Rohan ; Xylinas, Evanguelos ; Bhanvadia, Sumeet ; Sweiti, Hussein ; Urtishak, Karen ; Herrera-Imbroda, Bernardo

PURPOSE:

Standard of care for muscle-invasive bladder cancer (MIBC) is radical cystectomy (RC) with neoadjuvant cisplatin-based chemotherapy (NAC). However, many patients are ineligible for or refuse cisplatin. SunRISe-4 (ClinicalTrials.gov identifier: NCT04919512 ) is an open-label, multicenter, parallel-cohort phase II study assessing neoadjuvant gemcitabine intravesical system (TAR-200/gem-iDRS) plus cetrelimab or cetrelimab monotherapy in patients with MIBC.

METHODS:

Adults with Eastern Cooperative Oncology Group performance status 0-1, cT2-T4a N0M0, ineligible/refusing NAC, and planned for RC were randomly assigned 5:3, stratified by transurethral resection of bladder tumor completeness (residual tumor ≤3 cm permitted) and T stage, to receive TAR-200 plus cetrelimab (cohort 1) or cetrelimab monotherapy (cohort 2). The primary end point was pathologic complete response (pCR) at RC. Secondary end points included recurrence-free survival (RFS) and safety. Exploratory end points included pathologic overall response (pOR; ≤ypT1N0) and circulating tumor (ct) and urinary tumor (ut) DNA molecular residual disease (MRD). Side-by-side descriptive efficacy summary was planned.

RESULTS:

At the May 9, 2025, data cutoff, 159 patients were treated; 88 in cohort 1 and 46 in cohort 2 underwent RC. pCR, pOR, and 1-year RFS rates were 38%, 53%, and 77% in cohort 1 and 28%, 44%, and 64% in cohort 2, respectively. pCR rates were consistent across subgroups. No new safety signals were observed. Across cohorts, utDNA– status before RC (week 12) and utDNA clearance correlated with pCR ( P < 10 –5 and < 10 –3 , respectively). ctDNA– status at baseline and week 12 was associated with longer RFS compared with ctDNA+ status at the same time point ( P = .04 and 0.01, respectively).

CONCLUSION:

TAR-200 plus cetrelimab provided higher pCR, pOR, and 1-year RFS rates compared with cetrelimab monotherapy, supporting further investigation of the neoadjuvant combination in MIBC. utDNA and ctDNA MRD results support further investigation as biomarkers for residual local and nonlocal disease, respectively.

24 Feb 2026·CURRENT TOPICS IN MEDICINAL CHEMISTRY

An Expedition of FDA-Approved Anticancer Drugs in 2024: Synthetic Routes, Mechanisms of Action, and Clinical Indications.

Article

Author: Kurmi, Balak Das ; Priya, Sakshi ; Soni, Reena ; Cherian, Issac V ; Kasana, Shivani ; Islam, Md Mustahidul ; Das, Km Supriya ; Patel, Preeti

The year 2024 witnessed significant advancements in cancer therapy, with the U.S. Food and Drug Administration (FDA) approving 56 anticancer drugs for various malignancies. These approvals encompass 36 organic small molecules and 20 macromolecular monoclonal antibody conjugates, each with distinct mechanisms of action targeting key oncogenic pathways. Among the small molecules, kinase inhibitors such as Ribociclib, Imatinib Mesylate, and Nilotinib Hydrochloride Dihydrate modulate critical signaling cascades, while antimetabolites like Fluorouracil and Pemetrexed Disodium disrupt nucleotide biosynthesis. Other classes include DNA-damaging agents (Mitomycin, Gemcitabine Hydrochloride), immune modulators (Pomalidomide, Lenalidomide), and hormonal antagonists (Abiraterone Acetate, Erleada). The macromolecular therapeutics primarily consist of monoclonal antibody-based agents, such as Keytruda, Tecentriq, and Imfinzi, which enhance immune checkpoint inhibition, and antibody-drug conjugates like Enhertu and Elahere, which deliver cytotoxic payloads with high specificity. This review systematically examines the chemical synthesis, mechanisms of action, and therapeutic indications of these FDAapproved agents, emphasizing their role in improving patient outcomes. By analyzing their structural frameworks and biological targets, we aim to provide insights into current trends in anticancer drug development and potential future directions.

915

News (Medical) associated with Gemcitabine Hydrochloride

27 Apr 2026

·www.biospace.com

Cantargia Announces Early Results from Trial of Nadunolimab in MDS and AML

LUND, SE / ACCESS Newswire / April 27, 2026 / Cantargia AB (Nasdaq Stockholm:CANTA), a clinical-stage biotechnology company focused on antibody-based therapeutics targeting IL1RAP, today announced early results from the ongoing Phase 1b/2a clinical trial evaluating nadunolimab in combination with azacitidine in high-risk myelodysplastic syndrome (MDS), or in combination with azacitidine and venetoclax in patients with acute myelogenous leukemia (AML). The Phase 1b dose-escalation stage has now been completed, encompassing six patients in the high-risk MDS cohort and six in the AML cohort, and the study is progressing into the Phase 2a part. Nadunolimab in combination with azacitidine or azacitidine and venetoclax was generally well tolerated across both patient groups, with an acceptable safety profile. In the high-risk MDS cohort, six patients have been dosed, five of which are efficacy-evaluable. Notably, all five achieved complete remissions. The sixth patient is pending evaluation. These findings, while preliminary, suggest a promising signal of clinical activity for nadunolimab in combination with standard-of-care therapy in high-risk hematologic malignancies. The investigator-initiated trial is led by Gautam Borthakur, M.D., Ph.D., Professor of leukemia at The University of Texas MD Anderson Cancer Center. "We are encouraged by the early clinical responses observed in high-risk MDS patients, particularly given the high unmet medical need in this population," said Dr Gautam Borthakur. "Although the patient number remains small, the consistency of the responses and the manageable safety pro further study as we continue trial enrollment." "These data add to the growing body of clinical evidence supporting nadunolimab across our oncology programs," said Hilde Steineger, CEO of Cantargia . "Although based on a limited number of patients, the complete remission rate observed to date is encouraging and consistent with our understanding of IL1RAP targeting in combination with standard therapies." Further progress updates from the ongoing trial are expected later in 2026. The study will include approximately 40 patients in total. For details about the study [NCT06548230], reference is made to clinicaltrials.gov . For further information, please contact Hilde Steineger, CEO Telephone: +46 (0)46-275 62 60 E-mail: info@cantargia.com About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer and non-small cell lung cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed. Cantargia is listed on Nasdaq Stockholm (ticker:CANTA). More information about Cantargia is available at . About nadunolimab (CAN04) Nadunolimab is an antibody that binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and the development of resistance to chemotherapy. Nadunolimab has been investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316 , evaluated nadunolimab in combination with standard chemotherapies in patients with pancreatic ductal adenocarcinoma (PDAC) (gemcitabine/nab-paclitaxel) or non-small cell lung cancer (NSCLC) (platinum-based chemotherapies). Positive data show durable responses for combination therapy in 73 PDAC patients, resulting in a median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Intriguing efficacy was observed in a small group of non-squamous NSCLC patients post PD(L)-1 therapy. Attachments Cantargia Announces Early Results from Trial of nadunolimab in MDS and AML SOURCE: Cantargia View the original press release on ACCESS Newswire

Clinical ResultPhase 1AcquisitionPhase 2Immunotherapy

23 Apr 2026

·www.biospace.com

Orion Pharma initiates TEADCO Phase 1b/2 basket trial evaluating ODM-212 in combination with standard of care treatments in patients with select advanced solid tumours

ORION CORPORATION PRESS RELEASE 23 APRIL 2026 at 09.00 EEST Orion Pharma initiates TEADCO Phase 1b/2 basket trial evaluating ODM-212 in combination with standard of care treatments in patients with select advanced solid tumours Orion Corporation (Orion Pharma) today announced the initiation of a Phase 1b/2 basket trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer. The TEADCO trial is a multi-centre, open-label basket trial designed to evaluate the efficacy, safety, dose and tolerability of ODM-212 in combination with standard of care in these indications. The first cohort of the TEADCO trial evaluates ODM-212 in combination with ipilimumab and nivolumab as a first-line treatment for patients with advanced malignant pleural mesothelioma. ODM-212 has the potential to both exert direct anti-tumour activity and prevent emergence of treatment resistance to standard of care therapies in this indication. The second cohort evaluates ODM-212 in combination with sotorasib, a targeted KRAS inhibitor, for the treatment of NSCLC in patients with KRAS G12C mutation. This arm has two sub-cohorts: patients who have been previously treated with KRAS G12C inhibitor and patients who have not received KRAS G12C inhibitor as a prior treatment. ODM-212 has the potential to prevent or overcome treatment resistance to approved KRAS inhibitors in this setting. The third cohort evaluates ODM-212 in combination with chemotherapy (nab-paclitaxel/gemcitabine) for the treatment of metastatic adenocarcinoma of the pancreas aiming to improve treatment efficacy through combination therapy. “Initiation of the TEADCO Phase 1b/2 basket trial is another important milestone for the ODM-212 clinical development program and reflects our commitment to patients with difficult-to-treat cancers,” said Professor Outi Vaarala , Executive Vice President, Research & Development at Orion. “Together with the ongoing TEADES study, TEADCO highlights the versatility of ODM-212 both as monotherapy and in combination with other treatments. We believe ODM-212 has the potential to deliver meaningful clinical benefit, including by addressing treatment resistance to current standard of care therapies. We remain focused on advancing and expanding ODM-212 clinical development program.” About ODM-212 ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. About Malignant Pleural Mesothelioma Malignant Pleural Mesothelioma (MPM) is a rare and aggressive cancer that originates in the pleura—the thin membrane lining the lungs and chest wall. It accounts for about 80–90% of all mesothelioma cases and is strongly linked to asbestos exposure. Current treatments mainly include chemotherapy and immunotherapy. About NSCLC Non-small cell lung cancer (“NSCLC”) encompasses all epithelial lung cancers other than small cell lung cancer. The three main types are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC is the most common type of lung cancer, accounting for up to 85% of cases, with risk factors ranging from smoking to asbestos exposure and pulmonary fibrosis. Approximately 13% of NSCLC patients have KRAS G12C mutation. About Pancreatic Cancer Pancreatic cancer has a poor prognosis and remains one of the deadliest types of cancer. Treatment options are limited, chemotherapy being often the only option. About Orion Pharma Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being. Orion Corporation Contact person for media: Terhi Ormio, VP, Communications, Orion Corporation tel. +358 10 426 4646 Contact person for investors: Tuukka Hirvonen, Head of Investor Relations, Orion Corporation tel. +358 10 426 2721 Publisher: Orion Corporation Communications Orionintie 1A, FI-02200 Espoo, Finland

Clinical StudyImmunotherapy

23 Apr 2026

·www.edisononcology.com

Edison Oncology Presents New Preclinical Data onEO1001 and EO4426 Highlighting Differentiated Targetingof Cancer Resistance Pathways at AACR 2026

EO1001 demonstrates up to ~40-fold greater potency than osimertinib in EGFR ECD–mutant tumor models EO4426 (tezacitabine) demonstrates selective targeting of DNA replication machinery and resistance to CDA-mediated inactivation Menlo Park, CA – April 23, 2026 – Edison Oncology Holding Corp. (“Edison Oncology” or the “Company”) today announced presentation of new preclinical data from its EO1001 and EO4426 programs at the American Association for Cancer Research (AACR) Annual Meeting 2026, that took place April 17–22, 2026 in San Diego, California. “This work highlights two mechanistically distinct programs designed to address biologically defined resistance pathways in cancer,” said Jeffrey A. Bacha, chief executive officer of Edison Oncology. “The EO1001 data support its potential relevance in EGFR extracellular domain–mutant tumors, where currently approved therapies have limited activity, while the EO4426 findings further define a selective, replication-directed mechanism with potential utility in CDA-high tumors. Together, these results underscore our strategy to build a precision oncology pipeline grounded in translational science.” On April 21, 2026, Edison Oncology presented a poster entitled: Preclinical evaluation of EO1001 in EGFR-ECD mutant solid tumor models: Toward biomarker-directed therapy in the Experimental and Molecular Therapeutics session at the AACR annual meeting. EGFR alterations are found across multiple solid tumors. A subset of these—extracellular domain (ECD) mutations—drive tumor growth through ligand-independent signaling and are not well addressed by existing therapies and represent an unmet medical need in cancer. ECD mutations are particularly relevant in certain tumor types, including glioblastoma, where EGFR alterations occur in approximately 40–50% of cases and frequently involve the extracellular domain. They are also observed in colorectal cancer, where EGFR ECD mutations can emerge as a clinically relevant mechanism of acquired resistance to anti-EGFR therapies, reported in approximately 15–30% of resistant cases, as well as in subsets of neuroendocrine tumors. EO1001 is an oral, brain-penetrant, irreversible pan-ErbB inhibitor designed to target both wild-type and structurally altered EGFR. Early clinical signals in patients with EGFR ECD–mutant tumors in an ongoing Phase 1–2a study (ANZCTR: ACTRN12620000583943) support its potential as a biomarker-directed therapy in this patient population. To further characterize its activity, EO1001 was evaluated in patient-derived tumor models harboring clinically relevant EGFR ECD mutations. In these studies, EO1001 was tested in two patient-derived cell models carrying EGFR ECD mutations (R108K and A289T), with osimertinib as a comparator. Across both models, EO1001 demonstrated meaningful anti-tumor activity, with greater potency at earlier timepoints and sustained activity over time relative to osimertinib. In the R108K glioblastoma model, EO1001 showed approximately 40-fold greater potency at Day 5, while in the A289T neuroendocrine model, it maintained a consistent activity advantage through Day 7. These findings demonstrate activity across distinct EGFR ECD mutation classes and tumor types, supporting the continued clinical development of EO1001 as a biomarker-directed therapy for patients with ECD-driven disease. On April 22, 2026, Edison Oncology presented a poster entitled “Overcoming Cytidine Deaminase (CDA)–Mediated Resistance via EO4426 Dual DNA-Replication Targeting: Implications for CDAHigh Solid Tumors and Mesenchymal GBM” in the Experimental and Molecular Therapeutics –Novel Antitumor Agents session at the AACR Annual Meeting. EO4426 (tezacitabine) is a brain-penetrant cytidine analog designed to disrupt DNA replication in cancer cells through a dual mechanism. It inhibits both DNA polymerase-α (Polα) and ribonucleotide reductase (RNR), leading to depletion of DNA building blocks, replication stress, and accumulation of DNA damage in rapidly dividing tumor cells. Published third-party studies have shown that EO4426 is resistant to deactivation by cytidine deaminase (CDA), an enzyme that inactivates many standard therapies such as gemcitabine. CDA-mediated inactivation is a well-recognized mechanism of resistance and represents a significant unmet medical need across multiple tumor types. Tumors with high CDA expression—including mesenchymal glioblastoma, triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and ovarian cancer—may be particularly susceptible to treatment with EO4426. To further characterize its mechanism and selectivity, EO4426 was evaluated in a series of biochemical assays measuring activity across multiple DNA polymerases. These studies compared EO4426 to gemcitabine using purified enzyme systems to assess both target engagement and potential off-target effects. In these experiments, EO4426 demonstrated no measurable activity against non-replicative DNA polymerases (POLβ, POLγ, and POLθ) across the tested concentration range, indicating selective targeting of the DNA replication machinery rather than broad polymerase inhibition. In contrast, gemcitabine showed off-target inhibition of select polymerases at higher concentrations. This selective targeting supports a differentiated profile for EO4426 relative to gemcitabine, with a more focused impact on tumor cell replication and reduced off-target activity. Together, these results support future clinical development of EO4426 as a biomarker-directed therapy, particularly in CDA-high tumors and molecular subtypes such as mesenchymal or APOBECenriched glioblastoma. Edison Oncology Holding Corp. is a clinical-stage biopharmaceutical company developing a pipeline of first-in-class, small-molecule, biomarker-driven therapies designed to overcome key resistance mechanisms and address critical unmet needs in aggressive and underserved cancers. Leveraging existing clinical data and a modern understanding of cancer biology, Edison Oncology focuses on genetically defined cancers, advancing its programs through a capital-efficient combination of internal development and strategic partnerships while retaining meaningful development and commercial rights. To learn more, please visit https://www.edisononcology.com/ and follow us for updates on LinkedIn. Hayden IR Brett Maas(646) 536-7331brett@haydenir.com or James Carbonara(646)-755-7412james@haydenir.com Download PDF here Edison Oncology Presents New Preclinical Data onEO1001 and EO4426 Highlighting Differentiated Targetingof Cancer Resistance Pathways at AACR 2026 Edison Oncology Completes Target Enrollment in Phase 1/2a Orotecan™ Clinical Trial

Phase 1AACRClinical Result

100 Deals associated with Gemcitabine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	United States	Janssen Biotech, Inc.	09 Sep 2025
Locally Advanced Lung Non-Small Cell Carcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	Australia	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	Japan	Eli Lilly & Co.	25 Nov 2008
Bladder Cancer	Brazil	Libbs Farmacêutica Ltda.	26 May 2008
Biliary Tract Neoplasms	Japan	Eli Lilly & Co.	31 Aug 2001
Lymphoma	Japan	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	Japan	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	United States	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	United States	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	United States	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	United States	Eli Lilly & Co.	15 May 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced biliary tract cancer	Phase 3	Taiwan Province	InnoPharmax, Inc.	01 May 2026
Recurrent Bladder Cancer	Phase 3	United States	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	China	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Japan	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Argentina	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Belgium	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Brazil	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	France	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Germany	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Italy	Janssen Research & Development LLC	09 Apr 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06630325 (CTgov)	Phase 2	Ovarian Cancer \| Advanced Malignant Solid Neoplasm \| Pancreatic Cancer ... View more	6	Survey Administration+Abemaciclib+Gemcitabine (Arm I (Abemaciclib, Gemcitabine))	egbalpxjqd(miuoemismz) = dudbmsdzql rezfuhrlsp (eaxdhextqf, lvjdjiwyfx - zpbupopnbf) View more	-	28 Apr 2026
NCT06630325 (CTgov)	Phase 2		6	Survey Administration+abemaciclib+Pemetrexed (Arm II (Abemaciclib, Pemetrexed))	egbalpxjqd(miuoemismz) = ggutrmmhds rezfuhrlsp (eaxdhextqf, nzsqhnaltt - bseqgeuiug) View more	-	28 Apr 2026
NCT05494866 (IntenSify, AACR2026)	Phase 1	Pancreatic Cancer CYP3A5 expression	6	nab-paclitaxel+gemcitabine+cobicistat (Metastatic Pancreatic Cancer)	nsyqjdvwyg(zhuvmrqrit) = One patient was hospitalized after 6 weeks of treatment for grade 4 acute respiratory distress syndrome associated with LDH increase and lung ground-glass opacity in the CT scan. Two more asymptomatic cases of ground glass opacity associated with LDH increase were observed. fwuhispmvg (hnyynlhooi )	Negative	21 Apr 2026
NCT04535713 (AACR2026)	Phase 2	Hemangiosarcoma	9	Metronomic gemcitabine, doxorubicin, docetaxel and nivolumab	bfefxuizoy(hdcfwmfqqw) = odnwzgzcrl hjdblkkwro (txupotaayr, 8.224 - 9.441) View more	Positive	21 Apr 2026
NCT05498220 (CTgov)	Phase 2	Diffuse large B-cell lymphoma recurrent	5	Hyaluronidase+Polatuzumab vedotin+GCSF+Gemcitabine+cisplatin+Dexamethasone+Rituximab+PV	rpafnwvusc = mymqcdwzhm orvghwzgop (zmlsqzvwno, mtbajhayth - ugdjlobrlh) View more	-	16 Apr 2026
ESMO_ELCC2026	Not Applicable	Thymic Epithelial Tumor Second line	38	Capecitabine plus gemcitabine (C+G) (TC)	singujxcia(akosexairo) = dnksbfpufy lokbkdwoqo (svwuxozrmi, 8.0 - NA) View more	Positive	25 Mar 2026
ESMO_ELCC2026	Not Applicable	Thymic Epithelial Tumor Second line	38	Capecitabine plus gemcitabine (C+G) (T)	singujxcia(akosexairo) = fwoulttlsz lokbkdwoqo (svwuxozrmi, 25.6 - NA) View more	Positive	25 Mar 2026
ESMO_SRC2026	Not Applicable	Leiomyosarcoma Second line	108	Trabectedin	nljpfdngri(asfbpzzcao) = uiorlbchqo wanlqpwyeh (gcamlnkiay, 5.5 - 15.2) View more	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Leiomyosarcoma Second line	108	gemcitabine-based chemotherapy	nljpfdngri(asfbpzzcao) = ypfteacdzm wanlqpwyeh (gcamlnkiay, 3.8 - 6.4) View more	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Chondrosarcoma	10	Gemcitabine 1000 mg/m2 plus Oxaliplatin 100 mg/m2	tppwjmpcav(ukshotntbc) = Treatment was generally well tolerated, with limited grade 3 toxicity and one case of grade 5 thrombotic microangiopathy-associated to gemcitabine kpnkgwvaut (ycmugzkoyh )	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Leiomyosarcoma	336	Gemcitabine combined with docetaxel	eltcatmcbm(vhbgflophe) = rdogqejbec lxfdvjjifu (dcaqiojztg ) View more	Positive	09 Mar 2026
ESMO_SRC2026	Not Applicable	Perivascular epithelioid cell tumour	3	sirolimus + exemestane + gemcitabine	bxeuzyfizf(gborroyhfz) = lcscxnldmh gkutjkbktf (shgikmtifa ) View more	Positive	09 Mar 2026
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma Neoadjuvant	517	Gemcitabine 800 mg/m2	alwsnuvaxp(nyuhbzuunj): P-Value = 0.012 View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Muscle Invasive Bladder Carcinoma Neoadjuvant	517	Gemcitabine 1000 mg/m2	alwsnuvaxp(nyuhbzuunj): P-Value = 0.012 View more	Positive	26 Feb 2026

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