AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT07021950
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AK112 — DRUG
    AK112：20mg/kg，Q2W。Administered over 60 minutes (±10 minutes). For intolerable cases, infusion duration may extend up to 120 minutes. During treatment, dosing delays are allowed for up to 12 weeks (calculated from the last dose). AK112 may be resumed after 12 weeks under the following conditions: If treatment is paused due to glucocorticoid tapering for managing immune-related adverse events (irAEs);If treatment is paused due to adverse events unrelated or deemed unrelated to AK112; Resumption is permitted only if the investigator judges continued therapy beneficial, following discussion with relevant medical personnel.
  • FOLFIRI — DRUG
    FOLFIRI：Irinotecan, 180 mg/m² IV over 30-90 minutes (Day 1); Leucovorin (LV), 400 mg/m² IV over 2 hours (Day 1); 5-FU, 400mg/m²IV Day1, then 1200 mg/(m².d) ×2 days (total 2400 mg/m² ,IV over 46-48 hours).Q2W.
  • Bevacizumab — DRUG
    Bevacizumab：5 mg/kg，Q2W. The initial intravenous infusion should last approximately 90 minutes. If the first infusion is well tolerated, the duration of the second infusion can be reduced to approximately 60 minutes. Should the participant also tolerate the 60-minute infusion well, then all subsequent infusions may be administered over a period of approximately 30 minutes. Continuous monitoring for potential infusion-related reactions during the drip is required; if an infusion-related reaction occurs, the infusion rate should be promptly reduced or the infusion temporarily halted.

Study Details

This study is a multicenter, open-label phase II trial conducted to assess the safety and antitumor activity of Ivonescimab (AK112) plus FOLFIRI versus bevacizumab plus FOLFIRI as second-line treatment in subjects with MSS/pMMR metastatic colorectal cancer who have experienced intolerance to oxaliplatin-containing first-line therapy or disease progression, or recurrence within 6 months after oxaliplatin adjuvant therapy.

Key Dates

First listed
Jun 15, 2025
Start date
Aug 10, 2025
Status verified
Jun 2025
Primary completion
Oct 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AK112+FOLFIRI
    experimental group receives AK112 at 20 mg/kg via intravenous infusion on day 1 of each cycle (Q2W) combined with FOLFIRI chemotherapy (Q2W)
  • Active Comparator: bevacizumab+FOLFIRI
    Control group receives bevacizumab at 5 mg/kg via intravenous infusion on day 1 of each cycle (Q2W) combined with FOLFIRI chemotherapy (Q2W)

Primary Outcome Measure

PFS [ Time Frame: up to 24 months ]

Central Contacts

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