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
Brief Summary

This study is an open-label, multicenter study for Continued Characterization of Safetyand Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients withAdvanced 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.

Available
Treatment IND/Protocol
Advanced Solid Tumors
Cholangiocarcinoma

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.
Other Name: TT-00420

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861, United States

Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638, United States

Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168, United States

MD Anderson Cancer Center
Houston 4699066, Texas 4736286, United States

UW Carbone Cancer Center
Madison 5261457, Wisconsin 5279468, United States

Contacts

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

Hui Wang, MS
301-859-0848
wang_hui@transtherabio.com

Not Provided

TransThera Sciences (Nanjing), Inc.
NCT Number
MeSH Terms
Cholangiocarcinoma