A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC

Phase 2/3 Terminated 62 enrolled Suzhou Suncadia Biopharmaceuticals Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC.

Timeline

Start: 2021-06-22
Primary completion: 2024-04-17
Completion: 2024-04-17

Publications

Qiu MZ, Bai Y, Wang J, Gu K, Yang M, He Y, Yi C, Jin Y, Liu B, Wang F, Chen YK, Dai W, Jiang Y, Huang C, Xu RH, Luo HY. Addition of SHR-1701 to first-line capecitabine and oxaliplatin (XELOX) plus bevacizumab for unresectable metastatic colorectal cancer. Signal Transduct Target Ther. 2024 Dec 16;9(1):349. doi: 10.1038/s41392-024-02063-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Retlirafusp alfa	Protein / enzyme biologic	30 mg/kg	Intravenous
Background	BP102	Monoclonal antibody	7.5 mg/kg	Intravenous
Background	Capecitabine	Small molecule	2000 mg/m2	Oral
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC

Summary

Timeline

Publications

Drugs

Indications