This study is a multicenter, open-label, multi-cohort investigation exploring the efficacy and safety of ABP1011T tablets in participants with specific target solid tumors, providing a foundation for subsequent clinical research.
Based on safety and efficacy data from the prior Phase I/IIa clinical trial (Protocol Number: ABP1011T-I/II-01), priority enrollment is given to participants with advanced solid tumors including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma (excluding osteosarcoma). Cohort A (Cohort A1, Cohort A2, Cohort A3) comprises the small cell lung cancer cohort: Participants must have failed at least two prior systemic therapies. Cohort B enrolls participants with other advanced solid tumors (excluding osteosarcoma).
ABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose).

Start Date30 Dec 2025

Sponsor / Collaborator

GCP ClinPlus Co., Ltd.

NCT07260513

/ Active, not recruitingPhase 1

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GH2616 in Subjects With Advanced Solid Tumor.

GH2616 is a potent and selective inhibitor targeting KIF18A, exhibiting distinct and superior anticancer properties compared to other cell cycle and anti-mitotic drug targets, with significant inhibitory effects on TP53 mutant and WGD (whole genome doubling) or CIN (chromosomal instability) tumors. GH2616 regulates chromosome distribution and alignment, prolongs mitotic duration, and activates the spindle assembly checkpoint by inhibiting KIF18A activity, thereby arresting mitosis at the G2/M phase, inducing mitotic catastrophe, and ultimately achieving tumor suppression.
This study will evaluate the safety and tolerability of GH2616 in patients with advanced solid tumors, and determine its dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D).

Start Date27 Mar 2025

Sponsor / Collaborator

Suzhou Genhouse Bio Co., Ltd.

[+5]

NCT05284175

/ Not yet recruitingNot ApplicableIIT

A Prospective, Self-controlled Study to Explore Efficacy and Safety of Orelabrutinib in AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

Neuromyelitis optica spectrum disorder (NMOSD) is a chronic inflammatory demyelinating autoimmune disease of the central nervous system. NMOSD is a highly relapsing, severely disabling disease. AQP4-IgG positive NMOSD is related to a specific aquaporin 4 antibody (AQP4 IgG) produced by mature B cells. BTK is a key kinase in B cell receptor signal transduction pathway. Abnormal activation of BTK related signaling pathway can lead to autoantibody production and autoimmune diseases. Therefore, BTK can be developed as a new target for autoimmune diseases.

Start Date01 Apr 2022

Sponsor / Collaborator

Peking Union Medical College Hospital

[+2]

100 Clinical Results associated with GCP ClinPlus Co., Ltd.

0 Patents (Medical) associated with GCP ClinPlus Co., Ltd.

Literatures (Medical) associated with GCP ClinPlus Co., Ltd.

01 Jan 2024·PeerJ

The feasibility of the posterior tibial nerve-flexor hallucis brevis pathway applied in neuromuscular monitoring: a multicentric, controlled, and prospective clinical trial.

Article

Author: Chen, Weiqiang ; Li, Shangrong ; Cheng, Fang ; Chen, Zhijian ; Wang, Zhuodan ; Xie, Hanbin ; Li, Juan

This study aimed to investigate the clinical viability of utilizing the flexor hallucis brevis as an alternative site for neuromuscular monitoring compared to the conventional adductor pollicis. Patients were recruited from three medical centers. Cis-atracurium was administered, and two monitors were employed independently to assess neuromuscular blockade of the adductor pollicis and the ipsilateral flexor hallucis brevis, following a train of four (TOF) pattern until TOF ratios exceeded 0.9 or until the conclusion of surgery. Statistical analysis revealed significant differences in onset time, duration of no-twitch response, spontaneous recovery time, and total monitoring time between the two sites, with mean differences of -53.54 s, -2.49, 3.22, and 5.89 min, respectively (P < 0.001).The posterior tibial nerve-flexor hallucis brevis pathway presents a promising alternative for neuromuscular monitoring during anesthesia maintenance. Further investigation is warranted to explore its utility in anesthesia induction and recovery. Trial registration: The trial was registered at www.chictr.org.cn (20/11/2018, ChiCTR1800019651).

01 Jan 2021·The American journal of Chinese medicineQ2 · MEDICINE

Traditional Chinese Medicine Decoctions Significantly Reduce the Mortality in Severe and Critically Ill Patients with COVID-19: A Retrospective Cohort Study

Q2 · MEDICINE

Article

Author: Li, Xiu-Yang ; Duan, Li-Yun ; Tian, Jia-Xing ; Zhao, Sheng-Hui ; An, Xue-Dong ; Lian, Feng-Mei ; Jiang, Bo ; Tong, Xiao-Lin ; Xie, Ping ; Liu, Ping ; Luo, Peng-Cheng ; Yang, Qian ; Fan, An ; Sun, Qin-Guo ; Lang, Su-Ping ; Huang, Xiao-Dong ; Luo, Meng

Coronavirus disease (COVID-19) is a new infectious disease associated with high mortality, and traditional Chinese medicine decoctions (TCMDs) have been widely used for the treatment of patients with COVID-19 in China; however, the impact of these decoctions on severe and critical COVID-19-related mortality has not been evaluated. Therefore, we aimed to address this gap. In this retrospective cohort study, we included inpatients diagnosed with severe/critical COVID-19 at the Tongren Hospital of Wuhan University and grouped them depending on the recipience of TCMDs (TCMD and non-TCMD groups). We conducted a propensity score-matched analysis to adjust the imbalanced variables and treatments and used logistic regression methods to explore the risk factors associated with in-hospital death. Among 282 patients with COVID-19 who were discharged or died, 186 patients (66.0%) received TCMD treatment (TCMD cohort) and 96 (34.0%) did not (non-TCMD cohort). After propensity score matching at a 1:1 ratio, 94 TCMD users were matched to 94 non-users, and there were no significant differences in baseline clinical variables between the two groups of patients. The all-cause mortality was significantly lower in the TCMD group than in the non-TCMD group, and this trend remained valid even after matching (21.3% [20/94] vs. 39.4% [37/94]). Multivariable logistic regression model showed that disease severity (odds ratio: 0.010; 95% CI: 0.003, 0.037; [Formula: see text]¡ 0.001) was associated with increased odds of death and that TCMD treatment significantly decreased the odds of in-hospital death (odds ratio: 0.115; 95% CI: 0.035, 0.383; [Formula: see text]¡ 0.001), which was related to the duration of TCMD treatment. Our findings show that TCMD treatment may reduce the mortality in patients with severe/critical COVID-19.

01 Dec 2020·Frontiers of medicineQ3 · MEDICINE

Chinese herbal medicine reduces mortality in patients with severe and critical Coronavirus disease 2019: a retrospective cohort study

Q3 · MEDICINE

Article

Author: Li, Xiuyang ; Yang, Shuo ; Chen, Guohua ; Wang, Chuan ; Jia, Wen ; Qiao, Jie ; Su, Wen ; Lang, Suping ; Wei, Li ; Ke, Yuhe ; Xia, Ping ; Fan, Xuepeng ; Zhang, Ying ; Yang, Jiayao ; Fan, An ; Luo, Dan ; Zheng, Yujiao ; Meng, Qingbin ; Lian, Fengmei ; Tong, Xiaolin

This study aimed to evaluate the efficacy of Chinese herbal medicine (CHM) in patients with severe/critical coronavirus disease 2019 (COVID-19). In this retrospective study, data were collected from 662 patients with severe/critical COVID-19 who were admitted to a designated hospital to treat patients with severe COVID-19 in Wuhan before March 20, 2020. All patients were divided into an exposed group (CHM users) and a control group (non-users). After propensity score matching in a 1:1 ratio, 156 CHM users were matched by propensity score to 156 non-users. No significant differences in seven baseline clinical variables were found between the two groups of patients. All-cause mortality was reported in 13 CHM users who died and 36 non-users who died. After multivariate adjustment, the mortality risk of CHM users was reduced by 82.2% (odds ratio 0.178, 95% CI 0.076-0.418; P < 0.001) compared with the non-users. Secondly, age (odds ratio 1.053, 95% CI 1.023-1.084; P < 0.001) and the proportion of severe/critical patients (odds ratio 0.063, 95% CI 0.028-0.143; P < 0.001) were the risk factors of mortality. These results show that the use of CHM may reduce the mortality of patients with severe/critical COVID-19.

News (Medical) associated with GCP ClinPlus Co., Ltd.

03 Jun 2026

·www.prnewswire.com

ProBio and GCP ClinPlus Partner to Accelerate Clinical Trials in China

ProBio and GCP ClinPlus today announced a strategic collaboration designed to accelerate Investigator-Initiated Trials (IITs) in China and provide integrated, end-to-end clinical and development solutions for global biopharma customers. HOPEWELL, N.J., June 3, 2026 /PRNewswire/ -- As demand for Investigator-Initiated Trials (IITs) continues to grow, biopharma sponsors frequently encounter challenges related to operational efficiency, regulatory compliance, and fragmented vendor management in China. To address these complexities and streamline the pathway from early development to clinical operations, ProBio Inc. and GCP ClinPlus today announced a strategic collaboration designed to accelerate Investigator-Initiated Trials (IITs) in China and provide integrated, end-to-end clinical and development solutions for global biopharma customers. Continue Reading Advancing Next Generation Therapeutics Integrated Development and Clinical Execution This collaboration unites ProBio Inc.'s deep expertise in biologics and cell and gene therapy (CGT) CDMO services with GCP ClinPlus's robust capabilities in clinical trial execution and site management across China. The combined offering supports cutting-edge therapeutic modalities, including: In vivo CAR-T Gene therapy Cancer vaccines Gene editing therapies This unified service model simplifies clinical execution in China and accelerates study timelines. ProBio Inc. contributes extensive experience in early development and translational science, having supported over 40 IIT programs across diverse CGT pipelines. Complementing this, GCP ClinPlus brings significant clinical execution expertise, with a track record spanning more than 80 CGT projects and a well-established network of principal investigators across leading public and private hospitals in China. Streamlining the Bench-to-Bedside Pathway The partnership creates tangible value by reducing the disconnect between development and clinical execution. Both companies combine excellence in development, regulatory affairs, and clinical operations, covering project management, clinical monitoring, pharmacovigilance, and biostatistics, to ensure higher-quality and more efficient trial execution. This coordinated, two-party model offers international biopharma companies a simplified entry point into China's clinical research ecosystem, reducing vendor complexity while accelerating local trial execution. Allen Guo, CEO of ProBio, stated, "This marks an important step in how we support global innovators entering China. By bringing development and clinical execution closer together, we can help our clients move Investigator-Initiated Trials forward with greater speed, confidence, and simplicity." By integrating CMC, non-clinical studies, and clinical operations into one coordinated solution, the collaboration accelerates IIT start-up timelines and enables more efficient engagement with global biotech partners. Ultimately, this strategic alliance aims to help bring innovative, potentially life-saving therapies to patients faster. This partnership underscores a shared commitment to advancing therapeutic development and improving patient access to innovative treatments in China. Head of EU & US Regional Marketing: Tracy Humphries [[email protected]] SOURCE ProBio Inc. 21% more press release views with Request a Demo

100 Deals associated with GCP ClinPlus Co., Ltd.

100 Translational Medicine associated with GCP ClinPlus Co., Ltd.

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