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This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 as a monotherapy 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 |
|---|---|---|---|
| Arms | Experimental | SCTB41 of different doses,IV,every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTB41 | Drug | SCTB41 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) | Progression-free survival is defined as the time from the start of treatment with SCTB41 until the first documentation ofdisease 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 | |
|---|---|---|---|---|
| xiaoman zhang | Contact | +86-10-58628288-9134 | xiaoman_zhang@sinocelltech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Up to 2 years |
| Overall survival (OS) | Overall survival is defined as the time from the start of treatment with SCTB41 until death due to any cause. | Up to 2 years |