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NCT07150247

Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer

Recruiting now Phase 2 Last updated 26 September 2025
What this trial tests

Phase 2 trial testing Iparomlimab and Tuvonralimab in BRAF V600 Colorectal Cancer in 20 participants. Currently enrolling.

Timeline
1 June 2025
Primary endpoint
30 June 2027
30 June 2028

Quick facts

Lead sponsorSun Yat-sen University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 June 2025
Primary completion30 June 2027
Estimated completion30 June 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with BRAF V600 Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn if Iparomlimab and Tuvonralimab combined with bevacizumab and FOLFIRI (IB-FOLFIRI) is safe and effective in treating adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC). The main questions it aims to answer are: Does IB-FOLFIRI improve clinical outcomes compared with historical outcomes in this population? What is the safety profile of IB-FOLFIRI in patients with BRAF V600E-mutant mCRC? Participants will: Receive Iparomlimab and Tuvonralimab, bevacizumab, and FOLFIRI every two weeks Have blood samples and/or tumor tissue collected for biomarker analysis (e.g., ctDNA sequencing) Undergo regular imaging and clinical evaluations to assess treatment response and safety

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Iparomlimab and Tuvonralimab

Trials testing the same drug.

Other Sun Yat-sen University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07150247.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing