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

Sponsor
STCube, Inc.
Study ID
NCT06873763
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer (CRC)
  • Recurrent Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Mar 13, 2025
Start date
Jun 9, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nelmastobart 800 mg+Trifluridine/Tipiracil+Bevacizumab
    3 reducing doses of Trifluridine/Tipiracil will be administered to participants

Primary Outcome Measure

Incidence of DLT [ Time Frame: up to 6 months ]

Central Contacts

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