Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer

Sponsor
Akeso
Study ID
NCT06686030
Phase
PHASE2
Status
Recruiting
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Conditions

  • Platinum-sensitive Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AK112 low dose — DRUG
    10mg/kg, Q3W, ivgtt
  • Chemotherapy — DRUG
    ivgtt
  • Olaparib — DRUG
    bid, oral
  • AK112 high dose — DRUG
    20mg/kg, Q3W, ivgtt

Study Details

An Exploratory, Multi-cohort Phase II Study of combination therapy of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer(PSOC)

Key Dates

Start date
Feb 17, 2025
Status verified
Apr 2025
Primary completion
Oct 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1-10 (BRCAm)
    AK112(10mg/kg)+chemo for 4-6 cycles, AK112 (10mg/kg)+Olaparib maintenance
  • Experimental: Cohort 1-10B (non-BRCAm)
    AK112(10mg/kg)+chemo for 4-6cycles, AK112(10mg/kg) maintenance
  • Experimental: Cohort 1-20A (BRCAm)
    AK112(20mg/kg)+chemo for 4-6cycles, AK112(20mg/kg)+Olaparib maintenance
  • Experimental: Cohort 1-20B (non-BRCAm)
    AK112(20mg/kg)+chemo for 4-6cycles, AK112(20mg/kg) maintenance
  • Experimental: Cohort 2 (Prior ≥2L)
    AK112(20mg/kg)+Olaparib

Primary Outcome Measure

Progression-free survival (PFS) assessed by investigator per RECIST v1.1 [ Time Frame: up to 2 years ]

Central Contacts

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