Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC

Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting toxicity (DLT), while Phase 2 will evaluate objective response rate (ORR), including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Exploratory analyses will investigate immunomodulatory effects through tumor and peripheral blood s

Trial Details

NCT ID
NCT07281716
Phase
PHASE1 / PHASE2
Sponsor
Dan Feng
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Nadunolimab
  • Toripalimab
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Patients must have a pathologically confirmed diagnosis of non-MSI-H/pMMR CRC.
  • Patients must have progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and iri…
  • Patients must have at least 1 measurable target lesion at baseline ≥ 10mm in the longest diameter.
  • Patient must be willing and able to provide blood samples (6 heparinized, and two streck tubes, roughly 70 - 80 mL) at the time points indicated in…

For full eligibility, visit ClinicalTrials.gov.

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