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This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2618 injection combined with Toripalimab injection | Experimental | TQB2618 injection combined with Toripalimab injection,21 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2618 injection | Drug | Humanized IgG4 mab targeting TIM-3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose | Initial administration up to 21 days |
| phase II recommended dose | Optimal tolerated dose determined after the end of phase 1 | At the end of phase I, 1 subject received the first dose up to 21 days |
| objective response rate | The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation) | Baseline up to 96weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The time between the onset of first medication and disease progression (PD) or death before PD | disease progression before death,no more than 100 months |
| Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo, Doctor | Contact | 13911233048 | guoj307@126.com | |
| SiMing Li, Doctor | Contact | 13601308525 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab injection | Drug | Monoclonal antibody against Programmed death factor receptor 1 |
|
The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated
| Baseline up to 96 weeks |
| Overall Survival | From the time of the patient's first treatment to the time of death from any cause | No more than 100 months from the beginning of the first dose to death |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |