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There're 2 parts in this interventional study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK112 in combination with AK130 | Experimental |
| |
| AK112 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | Following a predefined dose and date. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with dose limiting toxicities (DLTs) | DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period. | During the first three weeks. |
| Number of subjects with adverse events (AEs) | AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. | From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy. |
| Objective Response Rate (ORR) (Phase II) | ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1). | Through study completion, an average of 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Phase Ib) | ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1). | Through study completion, an average of 2 years. |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenting Li | Contact | 18116403289 | wenting01.li@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| AK130 |
| Drug |
Following a predefined dose and date. |
|
DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1).
| Through study completion, an average of 2 years |
| Duration of Response (DoR) | The time from first documented evidence of CR or PR until time of first documented disease progression. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Time to response (TTR) | Time between date of start of treatment until first documented response (CR or PR). | From date of randomization until the date of first documented response, assessed up to 24 months |
| Progression Free Survival (PFS) | PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. | Through study completion, an average of 2 years. |
| Overall survival (OS) | OS is defined as the time from first dose until death due to any cause | Through study completion, an average of 2 years. |
| D004066 |
| Digestive System Diseases |