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This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-7367 + SHR-1316 Group | Experimental | SHR-7367 combined with SHR-1316. |
|
| SHR-7367 + SHR-1316 + AG Group | Experimental | SHR-7367 combined with SHR-1316 and AG. |
|
| SHR-7367 + AG Group | Experimental | SHR-7367 combined with AG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-7367 Injection | Drug | SHR-7367 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1 (IB Period): Dose-limiting toxicity (DLT). | Up to 28 days. | |
| Stage 1 (IB Period): Adverse events (AEs). | About 1 year. | |
| Stage 1 (IB Period): Serious adverse events (SAEs). | About 1 year. | |
| Phase II: Investigator-assessed objective response rate (ORR). | Assessed every 6 weeks, about 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed objective response rate (ORR). | Complete response + Partial response (CR+PR) based on RECIST v1.1. | Assessed every 6 weeks, about 1 year. |
| Disease control rate (DCR). | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Botao Zhu | Contact | +86-0518-82342973 | botao.zhu.bz19@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D007267 | Injections |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| SHR-1316 Injection | Drug | SHR-1316 injection. |
|
| Paclitaxel for Injection | Drug | Paclitaxel for injection (Albumin Bound). |
|
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine Hydrochloride for injection. |
|
| Assessed every 6 weeks, about 1 year. |
| Duration of response (DoR). | Time from documentation of tumor response to disease progression assessed among patients who had an objective response. | Assessed every 6 weeks, about 1 year. |
| Progression Free Survival (PFS). | Time from C1D1 to the first assessment of disease progression or death, whichever is earlier. | Assessed every 6 weeks, about 1 year. |
| Incidence and severity of Adverse events (AEs). | Time from C1D1 to the first assessment of disease progression or death, whichever is earlier. | Assessed approximately once every 1 month, about 1 year. |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |