Clinical Trial

Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated July 11, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The objective of this multi-center, single-group, open-label Phase Ib/II study is to evaluate the safety, pharmacokinetics, and efficacy of nelmastobart in combination with trifluridine/tipiracil and bevacizumab in metastatic or recurrent colorectal cancer patients with resistance or intolerance to oxaliplatin- and irinotecan-based chemotherapy, and to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the efficacy and safety of the combination therapy in BTN1A1-positive patients.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-03-07; most recent amendment 2025-07-08.
Status change: Active, Not Recruiting → Recruiting 2025-06-20
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-06-11
Trial Details
NCT Number NCT06873763
Lead Sponsor STCube, Inc.
Conditions Metastatic Colorectal Cancer (CRC), Recurrent Colorectal Cancer
Enrollment 52 participants
Start Date 2025-06-09
Primary Completion 2025-12 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-07-11