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

NCT07560124 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2026-04-30

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Fei Ma · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Tong Liu · The Second Affiliated Hospital of Harbin Medical University

  • Ting Luo · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-06
Primary Completion
2028-06-06
Completion
2030-09-14

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07560124 on ClinicalTrials.gov