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

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.

Trial Details

NCT ID
NCT06873763
Phase
PHASE1 / PHASE2
Sponsor
STCube, Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Nelmastobart 800 mg+Trifluridine/Tipiracil+ Bevacizumab
Locations (sample)
  • Seongnam-si, Gyeonggi-do, South Korea|37.43861,127.13778
  • Seoul, KR, South Korea|37.566,126.9784
  • Seoul, KR, South Korea|37.566,126.9784
  • Seoul, KR, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Subjects who participate in the study must meet all of the following inclusion criteria.
  • Adults ≥19 years old at the time of written informed consent
  • Patients with histologically/cytologically confirmed metastatic/recurrent colorectal cancer after failure of, or not eligible for oxaliplatin and i…
  • Subjects with at least one evaluable lesion, or non-measurable but evaluable lesion according to RECIST v1.1

For full eligibility, visit ClinicalTrials.gov.

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