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- |||| ZG005 / Suzhou Zelgen
New P2 trial, Metastases: Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - Aug 15, 2024
P2, N=90, Not yet recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- ||| ZG005 / Suzhou Zelgen, Zepsun (donafenib) / Suzhou Zelgen
Enrollment open, Metastases: A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor (clinicaltrials.gov) - Jun 14, 2024
P1/2, N=130, Recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Not yet recruiting --> Recruiting
- ||| ZG005 / Suzhou Zelgen
Enrollment open, Combination therapy, Metastases: ZG005-004: Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma. (clinicaltrials.gov) - Jun 13, 2024
P1/2, N=93, Recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ZG005 / Suzhou Zelgen
Preliminary results from a phase I expansion study of ZG005, a bispecific antibody targeting TIGIT and PD-1, as monotherapy in patients with advanced solid tumors. (Hall A; Poster Bd #: 90) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3012;
ZG005 has demonstrated a tolerable safety profile and encouraging anti-tumor activity during the FIH study. Expansion cohorts in specific advanced solid tumors are underway to warrant further development.
- |||| ZG005 / Suzhou Zelgen
New P1/2 trial, Combination therapy, Metastases: ZG005-004: Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma. (clinicaltrials.gov) - Apr 17, 2024
P1/2, N=93, Not yet recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- || ZG005 / Suzhou Zelgen
Enrollment open, Combination therapy, Metastases: Study of ZG005 in Combination With Paclitaxel?Platinum-based (clinicaltrials.gov) - Apr 2, 2024
P1/2, N=48, Recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Expansion cohorts in specific advanced solid tumors are underway to warrant further development. Not yet recruiting --> Recruiting
- || ZG005 / Suzhou Zelgen
New P1/2 trial, Combination therapy, Metastases: Study of ZG005 in Combination With Paclitaxel?Platinum-based (clinicaltrials.gov) - Feb 5, 2024
P1/2, N=48, Not yet recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- |||| ZG005 / Suzhou Zelgen, Zepsun (donafenib) / Suzhou Zelgen
New P1/2 trial, Metastases: A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor (clinicaltrials.gov) - Feb 2, 2024
P1/2, N=130, Not yet recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- ||||| ZG005 / Suzhou Zelgen
New P1/2 trial, Metastases: A Study of ZG005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jan 31, 2024
P1/2, N=484, Recruiting, Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- ZG005 / Suzhou Zelgen
Preclinical pharmacology and safety studies of ZG005: an anti-PD-1/TIGIT bispecific mAb in a phase I clinical trial for advanced tumors (Section 23; Poster Board #12) - Mar 14, 2023 - Abstract #AACR2023AACR_8472;
PK/TK analyses indicate a prolonged ZG005 receptor occupancy over 80%, consistent with in vitro binding results that are attribute to the S228P mutation in the IgG4 hinge region to prevent Fab exchange and enhance stability. The IND application of ZG005 has been approved by both FDA and NMPA, and the molecule is currently in phase I clinical trials for advanced solid tumors at escalated dosing of 0.3~20 mg/kg, Q3W, via i.v. administration.