A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer

Sponsor
Akeso
Study ID
NCT07560124
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • AK138D1 — DRUG
    Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
  • Ivonescimab — DRUG
    Enrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort.
  • treatment of physician's choice — DRUG
    Enrolled subjects will receive treatment of physician's choice according to one of the protocol-specified regimens selected by the investigator, based on the investigator's decision.

Study Details

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced breast cancer. Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.

Key Dates

Start date
Jun 6, 2026
Status verified
Apr 2026
Primary completion
Jun 6, 2028
Completion
Sep 14, 2030

Study Design

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

Arms

  • Experimental: AK138D1
    AK138D1 will be administered at pre-specified dose levels.
  • Experimental: AK138D1+ivonescimab
    AK138D1 and ivonescimab will be administered at pre-specified dose levels.
  • Active Comparator: Treatment of Physician's Choice
    Treatment of physician's choice will be administered according to one of the protocol-specified regimens selected by the investigator.

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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