RECRUITING

Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

Conditions

Cholangiocarcinoma Refractory/Relapsed Cholangiocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

Official Title

A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma

Quick Facts

Study Start:2023-12-20

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05948475

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease. 3. Documentation of FGFR2 fusion/rearrangement gene status 4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.	1. Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs. 2. Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment. 3. Subjects 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, including those that have previously undergone potentially curative therapy. 4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy. 5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval. 6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy. 7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)

Inclusion Criteria

Exclusion Criteria

1. ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
3. Documentation of FGFR2 fusion/rearrangement gene status
4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.

1. Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs.
2. Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment.
3. Subjects 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, including those that have previously undergone potentially curative therapy.
4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy.
5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy.
7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)

Contacts and Locations

Study Contact

Jean Fan, MD

CONTACT

86-25-86901107

fan_jean@transtherabio.com

Hui Wang

CONTACT

86-25-86901159

wang_hui@transtherabio.com

Principal Investigator

Milind Javle, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

UCLA Medical Center

Santa Monica, California, 90401

United States

Stanford Cancer Center

Stanford, California, 94305

United States

The University of Kansas Cancer Center

Westwood, California, 90024

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

United States

The University of Chicago Hospitals

Chicago, Illinois, 60601

United States

UMass Memorial Medical Center

Worcester, Massachusetts, 01655

United States

University of Michigan

Ann Arbor, Michigan, 48103

United States

Henry Ford

Detroit, Michigan, 48201

United States

University of Minnesota- Masonic Cancer Center, M Health Fairview

Minneapolis, Minnesota, 55455

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

United States

Messino Cancer Centers

Asheville, North Carolina, 28806

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Tennessee Oncology- Nashville

Nashville, Tennessee, 37203

United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75201

United States

Texas Oncology-Sammons Cancer Center

Dallas, Texas, 75246

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77002

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53202

United States

Collaborators and Investigators

Sponsor: TransThera Sciences (Nanjing), Inc.

Milind Javle, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20

Study Completion Date2026-08

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Refractory/Relapsed Cholangiocarcinoma

Additional Relevant MeSH Terms

Cholangiocarcinoma