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RECRUITING

NCT05948475

PHASE3

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

Sponsor: TransThera Sciences (Nanjing), Inc.

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-12-20

Completion Date

2026-08

Last Updated

2024-06-24

Healthy Volunteers

Conditions

Cholangiocarcinoma

Interventions

DRUG

Tinengotinib 8 mg

Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.

DRUG

Tinengotinib 10 mg

Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.

DRUG

Physician's Choice

For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.

Inclusion 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. Exclusion Criteria: 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)

Locations (87)

UCLA Medical Center

Santa Monica, California, United States

Stanford Cancer Center

Stanford, California, United States

The University of Kansas Cancer Center

Westwood, Los Angeles, California, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

The University of Chicago Hospitals

Chicago, Illinois, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford

Detroit, Michigan, United States

University of Minnesota- Masonic Cancer Center, M Health Fairview

Minneapolis, Minnesota, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Messino Cancer Centers

Asheville, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Tennessee Oncology- Nashville

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Oncology-Sammons Cancer Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Ordensklinikum Linz GmbH

Linz, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Institut Sainte Catherine - Institut du Cancer Avignon Provence

Avignon, France

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Hopital Beaujon

Clichy, France

Hopital Franco-Britannique - Fondation Cognacq-Jay

Levallois-Perret, France

Clinique de la Sauvegarde

Lyon, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Hopital Saint Antoine

Paris, France

Institut de Cancerologie Gustave Roussy

Villejuif, France

Krebszentrum Reutlingen

Baden, Germany

Krankenhaus Nordwest gGmbH

Frankfurt, Germany

Asklepios Klinik Altona

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)

Heidelberg, Germany

Ludwig-Maximilians-Universität München Kum

München, Germany

Clinica Oncologica, Ospedali Riuniti Umberto 1

Ancona, Italy

Candiolo Cancer Institute - FPO IRCCS

Candiolo, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

Istituto Europeo di Oncologia IRCCS

Milan, Italy

ASST Grande Ospedale Metropolitano Niguard

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Naples, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Azienda Ospedaliera Universitaria di Parma

Parma, Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Humanitas Research Hospital

Rozzano, Italy

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

Siena, Italy

AOUI Verona - Ospedale Borgo Roma

Verona, Italy

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

Warsaw, Poland

Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria

Lisbon, Portugal

Fundação Champalimaud

Lisbon, Portugal

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Dong-A University Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Yonsei University Health System - Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitari Vall d´Hebron

Barcelona, Spain

Hospital Universitario Reina Sofa

Córdoba, Spain

Clinica Universidad de Navarra

Madrid, Spain

HM Hospital Universitario Madrid Sanchinarro - CIOCC

Madrid, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario 12 de octubre

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Royal Marsden Hospital NHS

London, United Kingdom

UCG-1st floor central

London, United Kingdom

The Christie NHS Foundation Trust - Christie Hospital

Manchester, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (87)