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

Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Expanded Access

Recruiting Locations

University of Chicago Medical Center
Chicago, Illinois 60637

Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203

Sarah Cannon Research Institute
Nashville, Tennessee 37203

MD Anderson Cancer Center
Houston, Texas 77030

UW Carbone Cancer Center
Madison, Wisconsin 53705

More Details

Status
Available
Sponsor
TransThera Sciences (Nanjing), Inc.

Study Contact

Katie Hennessy, MS
267-627-0150
katie_hennessy@transtherabio.com

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.