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

• Conditions: Advanced Solid Tumors; Cholangiocarcinoma

• Registration Number: NCT06370013
• Lead Sponsor: TransThera Sciences (Nanjing), Inc.

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

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (5)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

UW Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States