A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK138D1, Ivonescimab, treatment of physician's choice.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
This is a multicenter, open-label Phase Ib/II study of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced breast cancer. The Phase Ib portion is designed to evaluate the safety, tolerability, and preliminary antitumor activity of AK138D1 in combination with ivonescimab. The Phase II portion is designed to evaluate the safety and efficacy of AK138D1 as monotherapy or in combination with ivonescimab.
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.
Primary outcome measures
- Adverse events (AEs) [Time frame: Up to approximately 2 years]
- Overall Response Rate (ORR) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
Secondary outcome measures (8)
- Peak Plasma Concentration (Cmax) [Time frame: Up to approximately 2 years]
- Area under the plasma concentration versus time curve (AUC) [Time frame: Up to approximately 2 years]
- Anti-drug antibodies (ADA) [Time frame: Up to approximately 2 years]
- Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Duration of response (DoR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Time to response (TTR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
- Overall Survival (OS) [Time frame: Up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Harbin Medical University Cancer Hospital — Harbin
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT07560124 · AK138D1-202