A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer
A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer
Sponsor: Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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 Endpoints
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
Anti-drug antibodies (ADA)
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 clini…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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