Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06370013 |
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Expanded Access Status :
Available
First Posted : April 17, 2024
Last Update Posted : April 17, 2024
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Sponsor:
TransThera Sciences (Nanjing), Inc.
Information provided by (Responsible Party):
TransThera Sciences (Nanjing), Inc.
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| Tracking Information | |||||||||
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| First Submitted Date | April 9, 2024 | ||||||||
| First Posted Date | April 17, 2024 | ||||||||
| Last Update Posted Date | April 17, 2024 | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors | ||||||||
| Brief 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. | ||||||||
| Study Type | Expanded Access | ||||||||
| Expanded Access Type | Treatment IND/Protocol | ||||||||
| Intervention | 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
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Expanded Access Status | Available | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT06370013 | ||||||||
| Current Responsible Party | TransThera Sciences (Nanjing), Inc. | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | TransThera Sciences (Nanjing), Inc. | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | TransThera Sciences (Nanjing), Inc. | ||||||||
| Verification Date | April 2024 | ||||||||