Malignant Solid Tumour
Conditions
Keywords
Advanced solid tumor failed with standard therapy
Brief summary
The primary objective is to characterize the safety profile of long-term exposure to SCB01A when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy profile will also be explored in this study.
Detailed description
This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed at least one cycles of treatment under the SCB01A-01 protocol.
Interventions
DRUGSCB01A
This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed 2 cycles of treatment under the SCB01A-01 protocol.
Sponsors
SynCore Biotechnology Co., Ltd.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who completed protocol SCB01A-01 and exhibited a favorable response or had no clinical evidence of disease progression (i.e. stable disease, partial response or complete response).
Exclusion criteria
Study participants meeting any of the following criteria will be excluded from enrollment: 1. Unwilling or unable to provide informed consent. 2. Unwilling or unable to comply with the requirements of the protocol. 3. Has unresolved toxicities from previous SCB01A-01 protocol.
Outcome results
None listed