Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors
Sponsor: TransThera Sciences (Nanjing), Inc.
ClinicalTrials ID:NCT06370013
This open-label, multicenter rollover study assesses the safety and tolerability of tinengotinib in adults with advanced solid tumors. Eligible participants must be benefiting from and tolerating tinengotinib in a TransThera parent study. They will continue their current dose, with potential reduction at physician discretion.
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Program Overview
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
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
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