Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-9839 combined with SHR-A2009 | Experimental |
| |
| SHR-9839 combined with SHR-A1921 | Experimental |
| |
| SHR-9839 combined with Pemetrexed + Carboplatin | Experimental |
| |
| SHR-9839 combined with Almonertinib | Experimental |
| |
| SHR-9839(sc) + SHR-1316 | Experimental |
| |
| SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc) | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-9839 for Injection | Drug | SHR-9839 for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) (phase IB) | 21 days after the first dose was administered to each subject, up to approximately 24 months. | |
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and laboratory abnormalities (phase IB) | Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0). | Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months. |
| Objective Response Rate (ORR) (phase II). | Evaluated using RECIST 1.1. | The first treatment lasted until disease progression, up to approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II) | Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0). | Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingkai Zhou | Contact | +8618205139261 | Qingkai.zhou@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy |
| Experimental |
|
| SHR-A1921 for Injection | Drug | SHR-A1921 for injection. |
|
| SHR-A2009 for Injection | Drug | SHR-A2009 for injection. |
|
| Almonertinib Mesilate Tablets | Drug | Almonertinib Mesilate Tablets. |
|
| Pemetrexed Disodium for Injection | Drug | Pemetrexed Disodium for Injection. |
|
| Carboplatin for injection | Drug | Carboplatin for injection. |
|
| Paclitaxel injection | Drug | Paclitaxel injection. |
|
| SHR-1316 Injection | Drug | SHR-1316 injection. |
|
| SHR-9839 for Injection (sc) | Drug | SHR-9839 for Injection (sc). |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
|
| ID | Term |
|---|---|
| D007267 | Injections |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided