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

Starting soon · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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 facts

Study ID

NCT07560124

Run by

Akeso

People needed

286

Starts

2026-06-06

Expected to finish

2030-09-14

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject must sign the written informed consent form (ICF) voluntarily;
• At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
• ECOG performance status score of 0 or 1;
• Has a life expectancy of ≥ 3 months;
• At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
• Adequate organ function.

You may not qualify if…

• Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
• Presence of active central nervous system (CNS) metastases.
• Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
• Untreated subjects with active hepatitis B or active hepatitis C;
• Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
• Known active syphilis infection;
• Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
• Other reasons for ineligibility as evaluated by the investigator.

Where it is running

• 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

Full record on ClinicalTrials.gov

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