NCT06370013

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

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Advanced Solid Tumors
• Cholangiocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

5 sites across 1 country: United States