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

N/ANo Longer AvailableNCT01151930

SynCore Biotechnology Co., Ltd.

Overview

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.

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.

Study Type

EXPANDED_ACCESS

Conditions

Malignant Solid Tumour

Interventions

SCB01ADRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Data from ClinicalTrials.gov

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