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NCT06370013 Clinical Trial

Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:
An Open Label, Multicenter Rollover Study for Continued Characterization of Safety and Tolerability of TT-00420 (Tinengotinib) Tablet Monotherapy in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT06370013
Other study ID # TT00420US14
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date April 2024
Source TransThera Sciences (Nanjing), Inc.
Contact Katie Hennessy, MS
Phone 267-627-0150
Email katie_hennessy@transtherabio.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This study is an open-label, multicenter study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors

Description:

This is a Rollover study. Only subjects who continue to receive clinical benefit from continuation of tinengotinib monotherapy and are tolerating tinengotinib at the time of enrollment are eligible to participate on this study. Subjects on this rollover study may continue to receive tinengotinib at the dose that they were previously receiving on the TransThera parent study and may continue for as long as the subject continues to benefit from treatment.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Subject is currently enrolled in a pre-defined TransThera-sponsored parent study and is receiving tinengotinib as a single agent. 2. Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator. Exclusion Criteria: 1. Subject has been permanently discontinued from tinengotinib in the parent protocol for any reason other than enrollment in the Rollover study 2. Subject does not meet the criteria specified in the parent protocol for continued treatment on study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tinengotinib
Subjects on this rollover study may continue to receive tinengotinib at the dose that they were previously receiving on the TransThera parent study. Dose may be decreased by one dose level from the previously-received dose upon study entry, based on physician discretion.

Locations
Country Name City State
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States University of Chicago Medical Center Chicago Illinois
United States MD Anderson Cancer Center Houston Texas
United States UW Carbone Cancer Center Madison Wisconsin
United States Sarah Cannon Research Institute Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
TransThera Sciences (Nanjing), Inc.

Country where clinical trial is conducted

United States, 

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