A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer

Sponsor
Akeso
Study ID
NCT07591090
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

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

Interventions

  • AK146D1 for injection — DRUG
    AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate.
  • AK112 Injection — DRUG
    AK112 Injection is a PD-1/VEGF bispecific antibody.

Study Details

This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer.

Key Dates

First listed
May 15, 2026
Start date
Jul 17, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2027
Completion
Feb 4, 2029

Study Design

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

Arms

  • Experimental: Arm A
    Participants in this group will receive AK146D1 combined with AK112 as i.v. infusion.
  • Experimental: Arm B
    Participants in this group will receive AK146D1 as i.v. infusion.

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: During the first 3 weeks of treatment in Safety Run-in Phase. ]

Central Contacts

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