A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors

Phase 2 Terminated 86 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open label, multi-cohort, multicenter Phase II study, the purpose of this study is to assess the efficacy and safety of envofolimab in combination with BD0801 injection with/without chemotherapy for the treatment of advanced solid tumors

Timeline

Start: 2021-12-22
Primary completion: 2023-07-26
Completion: 2023-07-26

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Business): “The study was terminated due to the sponsor's research and development strategy adjustment.”

paper The ORR was 10.0% (95% confidence interval (CI), 1.2-31.7) PMID 39883265 ↗

Publications

Ma L, Zhang Y, Fang Y, Hao C, Fan Q, Jiang D, Lu L, Su F, Yang C, Liu Z, Tian J, Sun X, Sun S, Cheng Y. Anti-PD-L1 envafolimab combined with anti-VEGF suvemcitug in pretreated solid tumors and hepatocellular carcinoma: an open-label phase II study with safety run-in stage. Invest New Drugs. 2025 Apr;43(2):181-190. doi: 10.1007/s10637-025-01506-x. Epub 2025 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	5-Fluorouridine	Small molecule	2400 mg/m2	—
Subject	Docetaxel	Small molecule	75 mg/m2	—
Subject	Envofolimab	Unknown	200 mg	—
Subject	Envofolimab	Unknown	300 mg	—
Subject	Irinotecan	Small molecule	180 mg/m2	—
Subject	Leucovorin	Small molecule	400 mg/m2	—
Subject	Suvemcitug	Monoclonal antibody	2 mg/kg	—