Clinical trial
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
Name
TT00420US14
Description
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
Trial arms
Treatment
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 names:
TT-00420
Size
-1
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.
Protocol
{'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 2, 'expandedAccessTypes': {'treatment': True}}
Updated at
2024-04-17
1 organization
1 product
2 indications
Organization
TransThera Sciences (Nanjing) Inc.Product
TinengotinibIndication
CancerIndication
Cholangiocarcinoma