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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-E58 | Other Identifier | Merck Sharp & Dohme LLC | |
| KEYNOTE-E58 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.
The primary objective of this study is to evaluate the safety and tolerability of JAB-BX102 monotherapy to determine the MTD(maximum tolerated dose) and RP2D(Recommended Phase 2 Dose) during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-BX102 is administered in combination with pembrolizumab during Dose Expansion phase in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation | Experimental | Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D. |
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| Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion | Experimental | JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-BX102 (anti-CD73 monoclonal antibody) | Biological | Administered by intravenous infusion (IV) |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) | A DLT is defined as the clinically significant TRAE(treatment-related adverse events) or abnormal laboratory values assessment during the first 21 days of Cycle 1 and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness. | First 21 days of Cycle 1 |
| Dose Escalation and Dose Expansion phase: Number of participants with adverse events | Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE 5.0. | Up to 3 years |
| Dose Expansion phase: Overall response rate (ORR) | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1. | Up to 3 years - from baseline to RECIST confirmed Progressive Disease |
| Expansion phase: Duration of response (DOR) | DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab | observed plasma concentration of JAB-BX102 | Up to 3 years |
| Dose Escalation phase: Overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China | ||
| Cancer Hospital Chinese Academy of Medical Sciences |
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| pembrolizumab (anti-PD-1 monoclonal antibody) | Biological | Administered by intravenous infusion (IV) |
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The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
| Up to 3 years - from baseline to RECIST confirmed Progressive Disease |
| Dose Escalation phase: Duration of response (DOR) | DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first. | Up to 3 years |
| Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR) | DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per CTCAE v1.1. | Up to 3 years |
| Dose Escalation and Dose Expansion phase: Progression-free survival (PFS) | PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first | Up to 3 years |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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