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The aim of this study is to observe and evaluate the tolerability, safety, pharmacokinetics and immunogenicity of SHR-1802 combined with adebrelimab in patients with advanced solid tumors, determine the RP2D of SHR-1802 combined with adebrelimab ± chemotherapy, and evaluate the efficacy of SHR-1802 combined with adebrelimab ± chemotherapy in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phase Ib:SHR-1802+Adebrelimab | Experimental |
| |
| phase II cohort 1: SHR-1802+Adebrelimab | Experimental |
| |
| phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT) | Experimental |
| |
| phase II cohort 3: SHR-1802+Adebrelimab + PDCT | Experimental |
| |
| phase II cohort 4: SHR-1802+Adebrelimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | 3 weeks | |
| Recommended phase II dose (RP2D) | up to 2 months | |
| ORR | Objective Response Rate, determined according to RECIST v1.1 criteria | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of Response, determined according to RECIST v1.1 criteria | up to 2 years |
| DCR | Disease Control Rate, determined according to RECIST v1.1 criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuni Wang, M.M | Contact | +86 15921207253 | shuni.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Dose-exploration:Six patients will be enrolled for tolerability observation. If ≥2 subjects in the previous dose level experienced DLTS, an additional 6 subjects in the other dose level were enrolled.
Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
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| SHR-1802 | Biological | Specified dose on specified days |
|
| Carboplatin/Cisplatin | Drug | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
|
| Paclitaxel/Nab-Paclitaxel/Pemetrexed | Drug | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
|
| up to 2 years |
| PFS assessed by investigator | Progression Free Survival, determined according to RECIST v1.1 criteria | up to 2 years |
| TTR | Time to Response,determined according to RECIST v1.1 criteria | up to 2 years |
| OS (overall survival) | From date of treatment start to any cause death or last follow-up | up to 2 years |
| 12-month OS rate | from the date of the first dose up to 2 years |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |