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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK138D1 | Experimental | AK138D1 will be administered at pre-specified dose levels. |
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| AK138D1+ivonescimab | Experimental | AK138D1 and ivonescimab will be administered at pre-specified dose levels. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK138D1 | Drug | Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence and severity of participants with adverse events | 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. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Derum drug concentrations in subjects at different time points after administration. | Up to approximately 2 years |
| Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenting Li | Contact | +86(0760)89873999 | clinicaltrials@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Fei Ma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Tong Liu | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Ivonescimab | Drug | Enrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort. |
|
| treatment of physician's choice | Drug | 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. |
|
The definite integral of the concentration of AK138D1 in blood plasma as a function of time.
| Up to approximately 2 years |
| Anti-drug antibodies (ADA) | Number of subjects with detectable anti-drug antibodies (ADA). | 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. | 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. | 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. | 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. | Up to approximately 2 years |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from randomization to death due to any cause. | Up to approximately 2 years |
| Ting Luo | West China Hospital | Principal Investigator |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China |
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| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |