Long-Term Compassionate Use Study for Continued Administration of SCB01A In Subjects Who Completed Treatment With SCB01A in the Previous Protocol # SCB01A -01
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.
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
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.
Type of Study:
United States: Food and Drug Administration
- Malignant Solid Tumour
- Advanced solid tumor failed with standard therapy