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 aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCTB39-1 | Experimental | SCTB39-1 of different doses, IV, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTB39-1 | Drug | SCTB39-1, IV |
|
| 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 SCTB39-1 until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuige Gao | Contact | +86-10-58628288 | cuige_gao@sinocelltech.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 2 years |
| Overall survival (OS) | Overall survival is defined as the time from the start of treatment with SCTB39-1 until death due to any cause. | Up to 2 years |