Delving into the Latest Updates on CC-1 with Synapse

Overview

Basic Info

Drug Type

Bispecific T-cell Engager (BiTE)

Synonyms-

Target

CD3 x PSMA

Action

stimulants, inhibitors

Mechanism

CD3 stimulants(T cell surface glycoprotein CD3 stimulants), PSMA inhibitors(Prostate-specific membrane antigen inhibitors)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Recurrent Prostate CarcinomaMetastatic castration-resistant prostate cancer

Inactive Indication

squamous cell lung carcinoma

Originator Organization

German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ)

Active Organization

German Cancer Research Center

University Hospital Tübingen

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 567CDR1-L

Sequence Code 631CDR2-L

Sequence Code 10251810ScFv

Sequence Code 316745519CDR1-H

Sequence Code 316745520CDR2-H

Sequence Code 316745521CDR3-H

Sequence Code 316745522CDR3-L

Sequence Code 316745523VH

Sequence Code 316745524VL

Sequence Code 316745525H

Sequence Code 316745527L

This trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format, which not only prolongs serum half-life, but most importantly reduces off-target T-cell activation with accordingly reduced side effects. The study entails a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then will be further evaluated in part II of the study (dose expansion part). After application of two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the disease setting of BCR of PC.

Start Date11 Nov 2022

Sponsor / Collaborator

University Hospital Tübingen

NCT04496674

/ TerminatedPhase 1/2IIT

PPhase-I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 as Single Agent and Combined With Checkpoint Blockade in Patients With Squamous Cell Carcinoma of the Lung

This trial is a phase I study in patients with metastatic non-small-cell lung cancer (NSCLC) after failure of second line therapy aiming to evaluate safety and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity developed within DKTK. CC-1 binds to human prostate-specific membrane antigen (PSMA) on tumor cells of squamous cell carcinoma of the lung (SCC) as well as to tumor vessels of SCC, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format which not only prolongs serum half-life but most importantly reduces off-target T cell activation with expected fewer side effects. Together with preemptive IL-6 receptor (IL-6R) blockade using tocilizumab, this allows for application of effective bsAb doses with expected high anticancer activity. The study comprises two phases: The first phase is a dose-escalation phase with concomitant prophylactic application of tocilizumab to evaluate the maximally tolerated dose (MTD) of CC-1. This is followed by a dose-expansion phase (also with prophylactic IL-6R blockade using tocilizumab). A translational research program comprising, among others, analysis of CC-1 half-life and the induced immune response as well as molecular profiling in liquid biopsies will serve to better define the mode of action of CC-1 and to identify biomarkers for further clinical development.

Start Date02 Feb 2022

Sponsor / Collaborator

German Cancer Research Center

[+1]

NCT04104607

/ RecruitingPhase 1IIT

First in Human Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma

This trial is a first in human (FIH) study in patients with castration resistant metastatic prostate cancer (CRPC) after failure of third-line therapy aiming to evaluate safety and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity developed within DKTK. CC-1 binds to human prostate-specific membrane antigen (PSMA) on prostate cancer cells as well as to tumor vessels of CRPC, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format which not only prolongs serum half-life but most importantly reduces off-target T cell activation with expected fewer side effects. Together with preemptive IL-6 receptor (IL-6R) blockade using tocilizumab, this allows for application of effective bsAb doses with expected high anticancer activity. The study comprises two phases. The first phase is a doseescalation phase with concomitant prophylactic application of tocilizumab to evaluate the maximally tolerated dose (MTD) of CC-1. This is followed by a dose-expansion phase (also with prophylactic IL-6R blockade using tocilizumab), as this approach has been shown to be efficient and beneficial for patients. A translational research program comprising, among others, analysis of CC-1 half-life and the induced immune response as well as molecular profiling in liquid biopsies will serve to better define the mode of action of CC-1 and to identify biomarkers for further clinical development.

Start Date15 Nov 2019

Sponsor / Collaborator

University Hospital Tübingen

[+1]

100 Clinical Results associated with CC-1

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100 Translational Medicine associated with CC-1

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100 Patents (Medical) associated with CC-1

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76

Literatures (Medical) associated with CC-1

01 Apr 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Outcomes of minimal residual disease at upfront debulking surgery compared with complete cytoreduction after neoadjuvant chemotherapy

Article

Author: Angeles, Martina Aida ; Martinez, Alejandra ; Bebia, Vicente ; Babin, Guillaume ; González, Elena Rodríguez ; Bataillon, Guillaume ; Bétrian, Sarah ; Aznar, Ana Luzarraga ; Cabarrou, Bastien ; Hernández, Alicia ; Guyon, Frédéric ; Romero, Violeta ; Ferron, Gwénaël ; Pérez-Benavente, Asunción ; Spagnolo, Emanuela ; Gil-Moreno, Antonio

Objective:

The aim of this study was to compare surgical complexity, post-operative complications, and survival outcomes between patients with minimal residual disease (completeness of cytoreduction (CC) score) CC-1 at the time of primary debulking surgery and those with complete cytoreduction (CC-0) at the time of interval debulking surgery.

Methods:

A retrospective multicenter study was conducted of patients with advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIIC–IV) who underwent cytoreductive surgery achieving either minimal or no residual disease between January 2008 and December 2015. Patients underwent either primary or interval debulking surgery after receiving ≥3 cycles of neoadjuvant chemotherapy. The sub-group of patients with primary debulking surgery/CC-1 was compared with those with interval debulking surgery/CC-0. Overall survival and disease-free survival were estimated using the Kaplan–Meier method.

Results:

A total of 549 patients were included, with upfront surgery performed in 175 patients (31.9%) and 374 patients (68.1%) undergoing interval debulking surgery. After primary debulking surgery, 157/175 (89.7%) had complete cytoreduction and 18/175 (10.3%) had minimal residual disease (primary debulking surgery/CC-1 group), while after interval debulking surgery, 324/374 (86.6%) had complete cytoreduction (interval debulking surgery/CC-0 group) and 50/374 (13.4%) had minimal residual disease. The rate of patients with peritoneal cancer index >10 was 14/17 (82.4%) for the primary debulking surgery/CC-1 group and 129/322 (40.1%) for the interval debulking surgery/CC-0 (p<0.001). The rate of patients with an Aletti score of ≥8 was 11/18 (61.1%) and 132/324 (40.7%), respectively (p=0.09) and the rate of major post-operative complications was 5/18 (27.8%) and 64/324 (19.8%), respectively (p=0.38). Overall median disease-free and overall survival were 19.4 months (95% CI 18.0 to 20.6) and 56.7 months (95%CI 50.2 to 65.8), respectively. Median disease-free survival for the primary debulking surgery/CC-1 group was 16.7 months (95% CI 13.6 to 20.0) versus 18.2 months (95% CI 16.4 to 20.0) for the interval debulking surgery/CC-0 group (p=0.56). Median overall survival for the primary debulking surgery/CC-1 group was 44.7 months (95% CI 34.3 to not reached) and 49.4 months (95% CI 46.2 to 57.3) for the interval debulking surgery/CC-0 group (p=0.97).

Conclusions:

Patients with primary debulking surgery with minimal residual disease and those with interval debulking surgery with no residual disease had similar survival outcomes. Interval surgery should be considered when achieving absence of residual disease is challenging at upfront surgery, given the lower tumor burden found during surgery.

01 Apr 2025·Contemporary Clinical Trials

Comparative effectiveness of two-way caring contacts texts vs one-way caring contacts texts vs enhanced usual care to reduce suicidal behavior in adolescents and adults: Protocol for the SPRING pragmatic randomized controlled trial

Article

Author: Pierce, Hailey ; Walton, Michael ; Sandoval, Daniel ; Radin, Anna K ; Austin, George ; Fouts, Tara ; Davis, Jessi ; Brown, Siobhan P ; Biss, Matthew ; Ratzliff, Anna ; McCutchan, Phoebe K ; Skeie, Anton ; Bronner, Jason ; Chan, Kwun C G ; Flint, Hilary ; McCue, Elizabeth ; Chase, Katrina ; Shaw, Jenny ; Fruhbauerova, Martina ; Comtois, Katherine Anne

BACKGROUND:

Suicide is a leading cause of death in US adolescents and adults. Caring Contacts - non-demanding messages of care and support - can significantly reduce suicide risk, but important implementation questions remain. Two-way Caring Contacts texts (CC2) (to which recipients can reply) have evidence of efficacy, but in practice health systems typically send one-way Caring Contacts texts (CC1) (to which recipients cannot reply). This manuscript describes the protocol for the Comparing Suicide Prevention Interventions to Guide Follow-up Care (SPRING) Trial.

METHODS:

The SPRING Trial is a pragmatic randomized controlled trial designed to compare the effectiveness of CC2 and CC1 versus UC, and to determine whether CC1 are noninferior to CC2 for preventing suicidal behavior. The sample includes 849 participants 12 years or older who screen positive for suicide risk and receive usual care at a primary care or behavioral health clinic. Participants are randomized 1:1:1 to CC2, CC1, or UC, with participants unaware of the alternative treatments. The state 988 crisis and suicide hotline delivers both active interventions and the feasibility of this model will be described. The primary outcome is suicidal behavior, measured using the Harkavy-Asnis Suicide Scale (HASS). Secondary outcomes include suicide attempts, suicidal ideation, ED utilization, hospitalization, and outpatient mental health treatment. Outcomes are assessed via surveys at baseline, 3, 6, and 12 months.

DISCUSSION:

CC2 is more operationally complex than CC1. If CC1 is non-inferior to CC2, it could more feasibly be implemented at scale, increasing access to effective suicide prevention care. Clinical trial registration The SPRING Trial is registered at ClinicalTrials.gov (NCT06128239).

01 May 2024·Annals of surgical oncology

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy to Treat Pseudomyxoma Peritonei of Ovarian Origin: A Retrospective French RENAPE Group Study

Article

Abstract:

Background:

Ovarian pseudomyxoma peritonei (OPMP) are rare, without well-defined therapeutic guidelines. We aimed to evaluate cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) to treat OPMP.

Methods:

Patients from the French National Network for Rare Peritoneal Tumors (RENAPE) database with proven OPMP treated by CRS/HIPEC and with histologically normal appendix and digestive endoscopy were retrospectively included. Clinical and follow-up data were collected. Histopathological and immunohistochemical features were reviewed.

Results:

Fifteen patients with a median age of 56 years were included. The median Peritoneal Cancer Index was 16. Following CRS, the completeness of cytoreduction (CC) score was CC-0 for 9/15 (60%) patients, CC-1 for 5/15 (33.3%) patients, and CC-2 for 1/15 (6.7%) patients. The median tumor size was 22.5 cm. After pathological review and immunohistochemical studies, tumors were classified as Group 1 (mucinous ovarian epithelial neoplasms) in 3/15 (20%) patients; Group 2 (mucinous neoplasm in ovarian teratoma) in 4/15 (26.7%) patients; Group 3 (mucinous neoplasm probably arising in ovarian teratoma) in 5/15 (33.3%) patients; and Group 4 (non-specific group) in 3/15 (20%) patients. Peritoneal lesions were OPMP pM1a/acellular, pM1b/grade 1 (hypocellular) and pM1b/grade 3 (signet-ring cells) in 13/15 (86.7%), 1/15 (6.7%) and 1/15 (6.7%) patients, respectively. Disease-free survival analysis showed a difference (p = 0.0463) between OPMP with teratoma/likely-teratoma origin (groups 2 and 3; 100% at 1, 5, and 10 years), and other groups (groups 1 and 4; 100%, 66.6%, and 50% at 1, 5, and 10 years, respectively).

Conclusion:

These results suggested that a primary therapeutic strategy using complete CRS/HIPEC for patients with OPMP led to favorable long-term outcomes.

100 Deals associated with CC-1

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
squamous cell lung carcinoma	Phase 2	Germany	German Cancer Research Center	02 Feb 2022
Recurrent Prostate Carcinoma	Phase 1	Germany	University Hospital Tübingen	11 Nov 2022
Metastatic castration-resistant prostate cancer	Phase 1	Germany	German Cancer Research Center	15 Nov 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04104607 (ASCO2024)	Phase 1/2	Prostatic Cancer First line PSMA	28	CC-1	xoagvbshyu(xmcbavzxcu) = max. 2° aglbhdlykb (reqnfafhnq ) View more	Positive	24 May 2024
NCT04104607 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Castration-Resistant Prostatic Cancer	24	CC-1	xkfhigrcwt(yjtvvhufdr) = the most frequently observed toxicity being cytokine release syndrome (CRS, max. 2°) (88%) hymopewfcb (uhrofyrngv )	Positive	26 May 2023
NCT04104607 (AACR2022) Manual	Phase 1	Advanced Prostate Carcinoma	14	CC-1	vhzexllhqx(ptvsjxbkvd) = Besides hypertension (observed in 50% of patients), no further CC-1 related toxicities (i.e., Xerostomia, or anaphylactic reaction) were observed. As expected, after prophylactic tocilizumab application decreased neutrophile counts and elevated liver enzymes were observed in 86% and 43% of patients, respectively. ulsjlwvzni (mphiddviwc )	Positive	15 Jun 2022

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