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

NCT07560124
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Phase
Phase 1/Phase 2
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Recruitment status
Not yet recruiting
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Participants
286
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Lead sponsor
Akeso
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Start date
2026-06-06
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Number of sites
3
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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.
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Short title
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer
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Official title
A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2030-09-14
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First posted
2026-04-30
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Registry last updated
2026-04-30
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Primary completion date
2028-06-06
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Start date
2026-06-06
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Participants
286
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Participant count basis
Estimated
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Planned participants
286
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Protocol amendments
0
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Number of sites
3
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Registry sponsor category
Industry
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Lead sponsor
Akeso
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07560124
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ClinicalTrials.gov ID
NCT07560124
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Adverse events (AEs)

    Timeframe: Up to approximately 2 years

    Incidence and severity of participants with adverse events

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

    Timeframe: Up to approximately 2 years

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

  1. Peak Plasma Concentration (Cmax)

    Timeframe: Up to approximately 2 years

    Derum drug concentrations in subjects at different time points after administration.

  2. Area under the plasma concentration versus time curve (AUC)

    Timeframe: Up to approximately 2 years

    The definite integral of the concentration of AK138D1 in blood plasma as a function of time.

  3. Anti-drug antibodies (ADA)

    Timeframe: Up to approximately 2 years

    Number of subjects with detectable anti-drug antibodies (ADA).

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

    Timeframe: Up to approximately 2 years

    Disease control rate (DCR) assessed according to RECIST v1.1.

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

    Timeframe: Up to approximately 2 years

    Duration of response (DoR) assessed according to RECIST v1.1.

  6. Progression Free Survival (PFS) assessed by investigator per RECIST v1.1

    Timeframe: Up to approximately 2 years

    PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.

  7. Time to response (TTR) assessed by the investigator per RECIST v1.1

    Timeframe: Up to approximately 2 years

    Time to response (TTR) is defined as the time to response based on RECIST v1.1.

  8. Overall Survival (OS)

    Timeframe: Up to approximately 2 years

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

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

  1. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
  2. Presence of active central nervous system (CNS) metastases.
  3. 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;
  4. Untreated subjects with active hepatitis B or active hepatitis C;
  5. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
  6. Known active syphilis infection;
  7. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
  8. Other reasons for ineligibility as evaluated by the investigator.
Sources for eligibility
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  • Cancer Hospital Chinese Academy of Medical SciencesBeijing, China
  • Harbin Medical University Cancer HospitalHarbin, China
  • West China Hospital of Sichuan UniversityChengdu, China
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)