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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Solid Tumour

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Advanced solid tumor failed with standard therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SCB01A

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

Shiah HS, Chiang NJ, Lin CC, Yen CJ, Tsai HJ, Wu SY, Su WC, Chang KY, Wang CC, Chang JY, Chen LT. Phase I Dose-Escalation Study of SCB01A, a Microtubule Inhibitor with Vascular Disrupting Activity, in Patients with Advanced Solid Tumors. Oncologist. 2021 Apr;26(4):e567-e579. doi: 10.1002/onco.13612. Epub 2020 Dec 18.

Reference Type DERIVED

PMID: 33245172 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCB01A-01-B

Identifier Type: -

Identifier Source: org_study_id