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NOT YET RECRUITING
NCT07560124
PHASE1/PHASE2

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

Sponsor: Akeso

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

286

Start Date

2026-06-06

Completion Date

2030-09-14

Last Updated

2026-04-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

AK138D1

Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.

DRUG

Ivonescimab

Enrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort.

DRUG

treatment of physician's choice

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.

Locations (3)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China