Advanced Breast CancerPhase 2NCT07591090
A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer
A Phase 2 study testing AK146D1 for injection and AK112 Injection in people with Advanced Breast Cancer, run by Akeso at 1 site in China.
Trial summary
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- AK146D1 for injection and AK112 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2026to 4 Feb 2029
- Phase
- Phase 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
- Be able to understand and voluntarily sign the written informed consent form.
- Aged of ≥ 18 years and ≤75 years.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- Patients with histologically confirmed locally advanced, recurrent, or metastatic breast cancer who are not eligible for curative surgical resection; and who have histologically or cytologically confirmed HER2-negative disease.
- At least one measurable lesion according to RECIST v1.1. Patients with only bone lesions or cutaneous lesions are not ineligible for enrollment.
- Have sufficient organ function.
- Females patients must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.
Who cannot join
- Patients had breast cancer amenable to curative treatment at study enrollment.
- Concurrent other histopathological types confirmed by tumor histology or cytology.
- Having other active malignancies within 3 years.
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Prior treatment with any therapy targeting Trop-2 or Nectin-4, or any chemotherapy agent targeting topoisomerase I.
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- Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks prior to the first dose.
- Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
- Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Patients with active autoimmune diseases requiring systemic treatment within 2 years.
- Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.
- Known to be positive for HIV and other infections.
- Previous history of severe hypersensitivity reactions.
- Live attenuated vaccines were received within 4 weeks.
- Patients with a history of mental illness and incapacitated or limited capacity.
- Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhimin Shao, Study Principal Investigator contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zhimin Shao, +86 021-64175590, szmgcp2016@163.com
About this study
Official title: A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Combined With AK112 in Patients With Advanced Breast Cancer
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- AK146D1 for injection, AK112 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK146D1 for injectionDrug
AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate.
AK112 InjectionDrug
AK112 Injection is a PD-1/VEGF bispecific antibody.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants in this group will receive AK146D1 combined with AK112 as i.v. infusion. Receives: Drug: AK146D1 for injection; Drug: AK112 Injection |
| Arm B | Experimental | Participants in this group will receive AK146D1 as i.v. infusion. Receives: Drug: AK146D1 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs)
DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Measured: During the first 3 weeks of treatment in Safety Run-in Phase.
Number of participants with adverse events (AEs)
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
Measured: From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1.
Measured: Up to approximately 2 years.
Secondary outcomes (7)
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years.
Disease Control Rate (DCR) assessed per RECIST v1.1
DCR is defined as the proportion of participants with CR, PR, or SD, assessed based on RECIST v1.1.
Measured: Up to approximately 2 years.
Duration of response (DoR) assessed by the investigator per RECIST v1.1
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) 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
TTR is defined as the time to objective response based on RECIST v1.1.
Measured: Up to approximately 2 years.
Overall survival (OS)
OS is defined as the time from the first dose to death from any cause.
Measured: Up to approximately 2 years.
Serum PK concentration of AK146D1 and AK112
Serum PK concentration of AK146D1 and AK112 in participants after administration.
Measured: From pre-dose to the end of the last dose, an average of 6 months.
Anti-drug antibodies (ADA)
The number and percentage of participants with detectable anti-drug antibodies (ADA)
Measured: From pre-dose to 30 days post end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start17 Jul 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion4 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591090
- Sponsor's protocol ID
- AK146D1-202
- Status last verified
- Jul 2026
- First submitted
- 9 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Combined With AK112 in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07591090
- Acronym / sponsor ID
- AK146D1-202
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 4 Feb 2029 (estimated)
- First posted
- 15 May 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.
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AK146D1 for injection, Drug: AK112 InjectionParticipants in this group will receive AK146D1 combined with AK112 as i.v. infusion. |
| Arm B | Experimental | Drug: AK146D1 for injectionParticipants in this group will receive AK146D1 as i.v. infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be able to understand and voluntarily sign the written informed consent form.
- Aged of ≥ 18 years and ≤75 years.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- Patients with histologically confirmed locally advanced, recurrent, or metastatic breast cancer who are not eligible for curative surgical resection; and who have histologically or cytologically confirmed HER2-negative disease.
Key exclusion criteria (16 listed)
- Patients had breast cancer amenable to curative treatment at study enrollment.
- Concurrent other histopathological types confirmed by tumor histology or cytology.
- Having other active malignancies within 3 years.
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
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 |
|---|---|---|
| AK146D1 for injectionAK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate. | Drug | Arm A, Arm B |
| AK112 InjectionAK112 Injection is a PD-1/VEGF bispecific antibody. | Drug | Arm A |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: During the first 3 weeks of treatment in Safety Run-in Phase.
DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Number of participants with adverse events (AEs)
Time frame: From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years.
ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1.
7 secondary outcomes
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years.
Disease Control Rate (DCR) assessed 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.
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.
Serum PK concentration of AK146D1 and AK112
Time frame: From pre-dose to the end of the last dose, an average of 6 months.
Anti-drug antibodies (ADA)
Time frame: From pre-dose to 30 days post end of treatment.
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 22 Jul 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.
Zhimin Shao, Study Principal Investigator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK146D1 for injection and AK112 Injection in people with Advanced Breast Cancer, run by Akeso at 1 site 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 Ting Liu (+86(0760)8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLTs) (time frame: During the first 3 weeks of treatment in Safety Run-in Phase.). The study lists 3 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 22 Jul 2026.