AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

Sponsor
Akeso
Study ID
NCT06951503
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Colorectal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • AK112 — DRUG
    iv, q2w
  • Oxaliplatin — DRUG
    iv, q2w
  • Irinotecan — DRUG
    iv, q2w
  • Leucovorin and 5-FU — DRUG
    iv, q2w
  • Bevacizumab — DRUG
    iv, q2w

Study Details

This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.

Key Dates

Start date
May 27, 2025
Status verified
Mar 2026
Primary completion
Jan 13, 2027
Completion
Jan 7, 2029

Study Design

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

Arms

  • Experimental: AK112 in combination with FOLFOXIRI
    AK112 in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus AK112.
  • Active Comparator: Bevacizumab in combination with FOLFOXIRI
    Bevacizumab in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus Bevacizumab .

Primary Outcome Measure

Progression-free survival (PFS) assessed by blinded independent central review (BICR) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Related Studies