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This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39-1with or without standard therapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCTB41+SCTB39-1 | Experimental | SCTB41 plus SCTB39-1 of different doses, IV, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTB41+SCTB39-1 | Drug | SCTB41 plus SCTB39-1 of different doses, IV, every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting toxicity(DLT) | Incidence of dose-limiting toxicities up to the Day 21 visit | From Day 0 up to Day 21 |
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1. | Up to 2 years |
| Progression-free survival (PFS) | The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongyang Gao, Doctor | Contact | +86-010-58628288 | dongyang_gao@sinocelltech.com |
| Name | Affiliation | Role |
|---|---|---|
| jiang | Cancer Hospital Chinese Academy of Medical Science Recruiting Beijing, China | Principal Investigator |
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| Up to 2 years |
| Overall survival (OS) | Overall survival is defined as the time from the start of treatment until death due to any cause. | Up to 2 years |