QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H/dMMR CRC

Sponsor
Qianfoshan Hospital
Study ID
NCT07009145
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • MSI-H/dMMR Colorectal Cancer
  • Metastatic Colorectal Cancer (CRC)
  • Unresectable Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • QL1706 — DRUG
    QL1706 (Iparomlimab and Tuvonralimab) is administered at a dose of 5 mg/kg via intravenous infusion on Day 1 of each 3-week cycle (Q3W).
  • Bevacizumab — DRUG
    Bevacizumab is administered at a dose of 7.5 mg/kg every 3 weeks (Q3W) via intravenous (iv) infusion.

Study Details

This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Eligible participants who meet the inclusion and exclusion criteria will provide written informed consent and receive QL1706 at 5.0 mg/kg and bevacizumab at 7.5 mg/kg on Day 1 of every 3-week cycle (Q3W), until disease progression or completion of 2 years of treatment. The primary endpoint of this study is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), PFS and OS rates at 6, 12, and 24 months, and safety.

Key Dates

First listed
Jun 6, 2025
Start date
Jun 27, 2025
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706 + Bevacizumab

Primary Outcome Measure

ORR [ Time Frame: approximately 6 months after the last subject participating in ]

Central Contacts

  • Jun Wang, Associate Director, Department of Oncology, MD, PHD
    0531-82169851
    [email protected]

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