NCT06873763

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: STCube, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer (CRC)
• Recurrent Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Nelmastobart 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.

Timeline

• Start date: 2025-06-09
• Primary completion: 2025-12-01
• Completion: 2027-03-01
• First posted: 2025-03-13
• Last updated: 2025-07-11

Locations

5 sites across 1 country: South Korea