A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer (NCT07560124) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer
China286 participantsStarted 2026-06-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events (AEs)
Timeframe: Up to approximately 2 years
2
Overall Response Rate (ORR) assessed by investigator per RECIST v1.1
. 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.