drugset / Trial / NCT07656038

Nelmastobart in Combination With Tas-102 and Bevacizumab in Recurrent/Metastatic Colorectal Cancer

NCT07656038

Phase 1 Not yet recruiting 45 enrolled STCube, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Nelmastobart(hSTC810) is a novel humanized monoclonal antibody that fuses on IgG4 and targets a novel immune checkpoint protein, BTN1A1+.This is an phase Ib bridging trial conducted in China to assess the safety, tolerability, and pharmacokinetic characteristics of Nelmastobart in combined with TAS-102 and Bevacizumab in Chinese participants with mCRC, and to verify that the safety results align with those from the Korean STCUBE-003 phase Ib trial. The phase Ib trial will also provide supportive data for conducting a randomized, double-blind, controlled Phase II study in China.

Timeline

Start
2026-06-30
Primary completion
2028-07-31
Completion
2028-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nelmastobart Monoclonal antibody 800 mg
Background Bevacizumab Monoclonal antibody 5 mg/kg
Background Bevacizumab Monoclonal antibody 35 mg/m2

Indications