TrialBridgeNCT07874438
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
Not Yet Recruiting · Not Applicable · The First Affiliated Hospital with Nanjing Medical University · registry updated 2026-10-14
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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)....
Inclusion
- \. Participants voluntarily agree to participate in this study, sign the informed consent form, and strictly comply with the study protocol requirements.
- \. Age ≥18 years and ≤75 years at enrollment, male or female.
- \. Histopathologically confirmed recurrent or metastatic colorectal adenocarcinoma; the enrolled population must have low-level microsatellite instability (MSI-L) or microsatellite stable (MSS)/mismatch repair-proficient (pMMR) tumors and be RAS and BRAF wild-type.
- \. At least one measurable tumor lesion per RECIST v1.1.
- \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- \. Expected survival ≥3 months.
Exclusion
- \. Radiotherapy or surgery within 30 days before initiation of study treatment (except prior diagnostic biopsy).
- \. Prior adjuvant chemotherapy for colorectal cancer (CRC), with an interval of less than 12 months between the end of adjuvant chemotherapy and the detection of disease recurrence or metastasis.
- \. Prior treatment with anti-EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or other EGFR-targeted therapies (e.g., cetuximab, nimotuzumab, panitumumab).
- \. Known hypersensitivity or anaphylactic reaction to any component of the study treatment.
- \. History of organ transplantation or autologous/allogeneic stem cell transplantation.
- \. History of other malignancies other than CRC within the past 5 years, except cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin.