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

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
Expanded Access Status : Available
First Posted : April 17, 2024
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
TransThera Sciences (Nanjing), Inc.

Study Description
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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

Condition or disease Intervention/treatment
Advanced Solid Tumors Cholangiocarcinoma Drug: Tinengotinib

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 Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06370013


Contacts
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Contact: Katie Hennessy, MS 267-627-0150 katie_hennessy@transtherabio.com
Contact: Hui Wang, MS 301-859-0848 wang_hui@transtherabio.com

Locations
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United States, Illinois
University of Chicago Medical Center Available
Chicago, Illinois, United States, 60637
United States, New York
Roswell Park Comprehensive Cancer Center Available
Buffalo, New York, United States, 14203
United States, Tennessee
Sarah Cannon Research Institute Available
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Available
Houston, Texas, United States, 77030
United States, Wisconsin
UW Carbone Cancer Center Available
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
TransThera Sciences (Nanjing), Inc.
More Information
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Responsible Party: TransThera Sciences (Nanjing), Inc.
ClinicalTrials.gov Identifier: NCT06370013    
Other Study ID Numbers: TT00420US14
First Posted: April 17, 2024    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms
Adenocarcinoma
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type