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

NCT06370013 | Unknown

• 1 other identifier: TT00420US14
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Advanced Solid Tumors; Cholangiocarcinoma

Interventions

Tinengotinib DRUG

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.

Also known as: TT-00420

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is currently enrolled in a pre-defined TransThera-sponsored parent study and is receiving tinengotinib as a single agent.
• Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.

You may not qualify if:

• Subject has been permanently discontinued from tinengotinib in the parent protocol for any reason other than enrollment in the Rollover study
• Subject does not meet the criteria specified in the parent protocol for continued treatment on study.

Sponsors & Collaborators

• TransThera Sciences (Nanjing), Inc.: lead

Study Sites (5)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

AVAILABLE

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

AVAILABLE

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

AVAILABLE

MD Anderson Cancer Center

Houston, Texas, 77030, United States

AVAILABLE

UW Carbone Cancer Center

Madison, Wisconsin, 53705, United States

AVAILABLE

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Katie Hennessy, MS

CONTACT

267-627-0150; katie_hennessy@transtherabio.com

Hui Wang, MS

CONTACT

301-859-0848; wang_hui@transtherabio.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (5)