Long-Term Compassionate Use Study for Continued Administration of SCB01A-01

SynCore Biotechnology

Status

Conditions: Malignant Solid Tumour

Treatments: Drug: SCB01A

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01151930

SCB01A-01-B

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.