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Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma

A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients With Advanced Cholangiocarcinoma

NCT04919642•TransThera Sciences (Nanjing), Inc.

View on ClinicalTrials.gov

Summary

This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.

Detailed Description

This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥ 18 years of age, at the time of signing informed consent
•2. Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts:
•* Cohort A1: FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor
•* Cohort A2: FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor
•* Cohort B: other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions
•* Cohort C: negative for FGFR alterations (FGFR wild-type)
•3. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors5
•4. Documentation of FGFR gene alteration status
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•6. Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:
+9 more criteria

Exclusion Criteria

•1. Women who are pregnant or lactating
•2. Women of child-bearing potential (WOCBP) who do not use adequate birth control
•3. Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment.
•4. Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy.
•5. Patients with the following mood disorders as judged by the Investigator or a psychiatrist:
•* Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
•* ≥ CTCAE grade 3 anxiety
•6. Impaired cardiac function or significant diseases, including but not limited to any of the following:
•* left ventricular ejection fraction (LVEF) \< 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO)
•* Congenital long QT syndrome
+19 more criteria

Locations (32)

Providence Cancer Center

Anchorage, Alaska, United States

City of Hope

Duarte, California, United States

University of California, Los Angeles, School of Medicine

Santa Monica, California, United States

USO Oncology Network- Rocky Mountain Cancer Centers

Denver, Colorado, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

University of Chicago Medical Center - Duchossis Center for Advanced Medicine

Chicago, Illinois, United States

University of Maryland - Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Health Center

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

December 7, 2021

Primary Completion Date

February 28, 2024

Completion Date

February 28, 2024

Last Updated

June 25, 2024

Enrollment

ACTUAL participants

Conditions

CholangiocarcinomaFGFR2 FusionFGFR2 Gene MutationFGFR1 AlterationFGFR3 Alteration

Interventions

TT-00420

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma

Inclusion Criteria

Exclusion Criteria

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