A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Cetuximab and mFOLFIRI Regimen as First-Line Treatment for Recurrent or Metastatic Colorectal Cancer

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Minor Study First Submitted
This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the efficacy and safety of iparomlimab and tuvonralimab (QL1706) combined with cetuximab and mFOLFIRI as first-line treatment for recurrent or metastatic colorectal cancer. A total of 55 participants with low-level microsatellite instability (MSI-L) or microsatellite stable (MSS)/mismatch repair-proficient (pMMR) and RAS/BRAF wild-type tumors will be enrolled. Enrolled participants will receive iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + irinotecan (180 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-FU (400 mg/m², Q2W, Day 1). After 12 cycles of the chemotherapy phase, participants who achieve CR, PR, or SD will then receive maintenance therapy with iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-fluorouracil (5-FU) (400 mg/m², Q2W, Day 1) until disease progression, intolerable toxicity, investigator determination that the participant is no longer benefiting, withdrawal of informed consent, completion of 2 years of iparomlimab and tuvonralimab treatment, or other protocol-specified reasons.
Trial Details
NCT Number NCT07874438
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions
(from sponsor)
Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov