> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ak138d1-alone-or-in-combination-with-ivonescimab-ee8196b7-245c-43d3-adf2-58716f129518 > Record changed: 2026-11-04 # A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer NCT07560124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) Participants 286 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) Start date 2026-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Short title** A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Official title** A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Dates **Completion date** 2030-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **First posted** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Registry last updated** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Primary completion date** 2028-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Start date** 2026-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Size and sites **Participants** 286 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Planned participants** 286 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Identifiers **Registry ID** NCT07560124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **ClinicalTrials.gov ID** NCT07560124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Sites - Cancer Hospital Chinese Academy of Medical SciencesBeijing, China - Harbin Medical University Cancer HospitalHarbin, China - West China Hospital of Sichuan UniversityChengdu, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07560124) ## Related records ### Drugs (1) - [Ivonescimab](https://trialight.com/data/asset/ivonescimab-abc25b61-44c5-4a6f-99eb-c59828f17211.md) ### Lead sponsors (1) - [Akeso](https://trialight.com/data/company/akeso-7431fe55-b110-4314-a667-5e8a9af91fc3.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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