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

NCT07560124 | Not Yet Recruiting Phase 1

• 1 other identifier: AK138D1-202
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 3

Brief 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

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  Incidence and severity of participants with adverse events

  Up to approximately 2 years

• Overall Response Rate (ORR) assessed by investigator per RECIST v1.1

  ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

  Up to approximately 2 years

Secondary Outcomes (8)

• Peak Plasma Concentration (Cmax)

  Up to approximately 2 years

• Area under the plasma concentration versus time curve (AUC)

  Up to approximately 2 years

• Anti-drug antibodies (ADA)

  Up to approximately 2 years

• Disease Control Rate (DCR) assessed by investigator per RECIST v1.1

  Up to approximately 2 years

• Duration of response (DoR) assessed by the investigator per RECIST v1.1

  Up to approximately 2 years

Study Arms (3)

AK138D1

EXPERIMENTAL

AK138D1 will be administered at pre-specified dose levels.

Drug: AK138D1

AK138D1+ivonescimab

EXPERIMENTAL

AK138D1 and ivonescimab will be administered at pre-specified dose levels.

Drug: AK138D1; Drug: Ivonescimab

Treatment of Physician's Choice

ACTIVE COMPARATOR

Treatment of physician's choice will be administered according to one of the protocol-specified regimens selected by the investigator.

Drug: treatment of physician's choice

Interventions

AK138D1 DRUG

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

AK138D1; AK138D1+ivonescimab

Ivonescimab DRUG

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

AK138D1+ivonescimab

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.

Treatment of Physician's Choice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fei Ma

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Tong Liu

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Ting Luo

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenting Li

CONTACT

+86(0760)89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): June 6, 2026
• Primary Completion (Estimated): June 6, 2028
• Study Completion (Estimated): September 14, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (3)