Breast CancerPhase 1/2NCT07560124
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer
A Phase 1/2 study testing AK138D1, Ivonescimab and treatment of physician's choice in people with Breast Cancer, run by Akeso at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AK138D1, Ivonescimab and treatment of physician's choice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 3 sitesChina
- Study dates
- 6 Jun 2026to 14 Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Fei Ma
West China Hospital of Sichuan University
Chengdu, Sichuan
Ting Luo
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Tong Liu
About this study
Official title: A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- AK138D1, Ivonescimab, treatment of physician's choice
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK138D1Drug
Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
IvonescimabDrug
Enrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort.
treatment of physician's choiceDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| AK138D1 | Experimental | AK138D1 will be administered at pre-specified dose levels. Receives: Drug: AK138D1 |
| AK138D1+ivonescimab | Experimental | AK138D1 and ivonescimab will be administered at pre-specified dose levels. Receives: Drug: AK138D1; Drug: Ivonescimab |
| Treatment of Physician's Choice | Active comparator | Treatment of physician's choice will be administered according to one of the protocol-specified regimens selected by the investigator. Receives: Drug: treatment of physician's choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and severity of participants with adverse events
Measured: Up to approximately 2 years
Overall Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Measured: Up to approximately 2 years
Secondary outcomes (8)
Peak Plasma Concentration (Cmax)
Derum drug concentrations in subjects at different time points after administration.
Measured: Up to approximately 2 years
Area under the plasma concentration versus time curve (AUC)
The definite integral of the concentration of AK138D1 in blood plasma as a function of time.
Measured: Up to approximately 2 years
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Measured: Up to approximately 2 years
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Measured: Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1.
Measured: Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
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.
Measured: Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
Time to response (TTR) is defined as the time to response based on RECIST v1.1.
Measured: Up to approximately 2 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start6 Jun 2026 (estimated)
- Primary completion6 Jun 2028 (estimated)
- Study completion14 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Ma, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesTong Liu, Principal investigator, The Second Affiliated Hospital of Harbin Medical UniversityTing Luo, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560124
- Sponsor's protocol ID
- AK138D1-202
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07560124
- Acronym / sponsor ID
- AK138D1-202
- Conditions
- Breast Cancer
- Keywords
- Breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2026 (estimated)
- Primary completion
- 6 Jun 2028 (estimated)
- Study completion
- 14 Sep 2030 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AK138D1 | Experimental | Drug: AK138D1AK138D1 will be administered at pre-specified dose levels. |
| AK138D1+ivonescimab | Experimental | Drug: AK138D1, Drug: IvonescimabAK138D1 and ivonescimab will be administered at pre-specified dose levels. |
| Treatment of Physician's Choice | Active comparator | Drug: treatment of physician's choiceTreatment of physician's choice will be administered according to one of the protocol-specified regimens selected by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK138D1Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort. | Drug | AK138D1, AK138D1+ivonescimab |
| IvonescimabEnrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort. | Drug | AK138D1+ivonescimab |
| treatment of physician's choiceEnrolled 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. | Drug | Treatment of Physician's Choice |
Primary outcome
Adverse events (AEs)
Time frame: Up to approximately 2 years
Incidence and severity of participants with adverse events
Overall Response Rate (ORR) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fei Ma principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tong Liu principal investigator
The Second Affiliated Hospital of Harbin Medical University
Ting Luo principal investigator
West China Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK138D1, Ivonescimab and treatment of physician's choice in people with Breast Cancer, run by Akeso at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenting Li (+86(0760)89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.