RecruitingPhase 1Phase 2NCT06873763

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

A Single-arm, Phase Ib/2 Study of Nelmastobart in Combination With Trifluridine/Tipiracil and Bevacizumab in Metastatic/Recurrent Colorectal Cancer Patients With Resistance or Intolerance to Oxaliplatin and Irinotecan-based Chemotherapy

Sponsor

STCube, Inc.

Enrollment

52 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer (CRC)Recurrent Colorectal Cancer

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — nelmastobart (an immunotherapy), trifluridine/tipiracil (a chemotherapy pill), and bevacizumab (a drug that blocks tumor blood vessel growth) — in people with colorectal cancer that has spread or come back after prior treatment. **You may be eligible if...** - You are 19 years old or older - You have colorectal cancer that has spread (metastatic) or returned after previous chemotherapy treatments (oxaliplatin and irinotecan-based regimens) that are no longer working or not suitable for you - You have at least one measurable or trackable tumor - You are in good health (ECOG performance status 0 or 1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have not yet tried standard chemotherapy options for colorectal cancer - Your blood counts or organ function fall below required thresholds - You have other conditions that the study team determines make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab

Trifluridine/tipiracil is dose-deescalated from 35 mg/m² to 30 mg/m² and 25 mg/m² to determine the RP2D, in combination with fixed doses of Nelmastobart and Bevacizumab, in patients with metastatic colorectal cancer who are refractory or intolerant to prior oxaliplatin- and irinotecan-based chemotherapy.