NCT07560124Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 24 Apr 2026
- Start date
- 6 Jun 2026
- Primary completion date
- 6 Jun 2028
- Lead sponsor
- Akeso
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07560124
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 286
- From 6 Jun 2026 to the primary completion date, 6 Jun 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
- 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;
Other illness
- 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
- Presence of active central nervous system (CNS) metastases.
- Other reasons for ineligibility as evaluated by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.