Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma (FIRST-308)

April 25, 2024 updated by: TransThera Sciences (Nanjing), Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Linz, Austria
        • Not yet recruiting
        • Ordensklinikum Linz GmbH
        • Principal Investigator:
          • Bernhard Doleschal
      • Wiener Neustadt, Austria
        • Not yet recruiting
        • Landesklinikum Wiener Neustadt
        • Principal Investigator:
          • Birgit Gruenberger
  • Belgium
      • Antwerp, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Antwerpen
        • Principal Investigator:
          • TimonV andamme
      • Gent, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Gent
        • Principal Investigator:
          • Karen P Geboes
      • Leuven, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Leuven
        • Principal Investigator:
          • Jeroen Dekervel
  • France
      • Avignon, France
        • Not yet recruiting
        • Institut Sainte Catherine - Institut du Cancer Avignon Provence
        • Principal Investigator:
          • Laurent Mineur
      • Besancon, France
        • Not yet recruiting
        • Centre Hospitalier Régional Universitaire de Besançon
        • Principal Investigator:
          • Angelique Vienot
      • Clichy, France
        • Not yet recruiting
        • Hopital Beaujon
        • Principal Investigator:
          • Mohamed Bouattour
      • Levallois-Perret, France
        • Not yet recruiting
        • Hopital Franco-Britannique - Fondation Cognacq-Jay
        • Principal Investigator:
          • Benoist Chibaudel
      • Lyon, France
        • Not yet recruiting
        • Clinique de la Sauvegarde
        • Principal Investigator:
          • Yann Molin
      • Montpellier, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Montpellier
        • Principal Investigator:
          • Eric Assenat
      • Paris, France
        • Not yet recruiting
        • Hopital Saint Antoine
        • Principal Investigator:
          • Violaine Ozenne
      • Villejuif, France
        • Not yet recruiting
        • Institut de Cancerologie Gustave Roussy
        • Principal Investigator:
          • Antoine Hollebecque
  • Germany
      • Baden, Germany
        • Active, not recruiting
        • Krebszentrum Reutlingen
      • Frankfurt, Germany
        • Not yet recruiting
        • Krankenhaus Nordwest gGmbH
        • Principal Investigator:
          • Thorsten O Goetze
      • Hamburg, Germany
        • Not yet recruiting
        • Asklepios Klinik Altona
        • Principal Investigator:
          • Dirk Arnold
      • Hannover, Germany
        • Not yet recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Vogel Saborowski
      • Heidelberg, Germany
        • Active, not recruiting
        • Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)
      • München, Germany
        • Not yet recruiting
        • Ludwig-Maximilians-Universität München Kum
        • Principal Investigator:
          • Volker Heinemann
  • Italy
      • Ancona, Italy
        • Not yet recruiting
        • Clinica Oncologica, Ospedali Riuniti Umberto 1
        • Principal Investigator:
          • Rossana Berardi
      • Meldola, Italy
        • Active, not recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Italy
        • Not yet recruiting
        • Istituto Europeo di Oncologia IRCCS
        • Principal Investigator:
          • Nicola Fazio
      • Milano, Italy
        • Not yet recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Principal Investigator:
          • Monica Niger
      • Milano, Italy
        • Not yet recruiting
        • ASST Grande Ospedale Metropolitano Niguard
        • Principal Investigator:
          • Salvatore Siena
      • Napoli, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
        • Principal Investigator:
          • Erika Martinelli
      • Napoli, Italy
        • Not yet recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
        • Principal Investigator:
          • Antonio Avallone
      • Parma, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria di Parma
        • Principal Investigator:
          • Ingrid Garajova
      • Pisa, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Pisana
        • Principal Investigator:
          • Gianluca Masi
      • Rozzano, Italy
        • Not yet recruiting
        • Humanitas Research Hospital
        • Principal Investigator:
          • Lorenza Rimassa
      • Siena, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
        • Principal Investigator:
          • Michele Maio
      • Verona, Italy
        • Not yet recruiting
        • AOUI Verona - Ospedale Borgo Roma
        • Principal Investigator:
          • Davide Melisi
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Recruiting
        • Dong-A University Hospital
        • Principal Investigator:
          • Sung Yong Oh
        • Contact:
          • Minseong Seon
        • Sub-Investigator:
          • Suee Lee
        • Sub-Investigator:
          • Seok Jae Huh
        • Sub-Investigator:
          • Hye Ryeon Kim
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Il Hwan Kim
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Myoung Joo Kang
        • Sub-Investigator:
          • Yong June Lee
      • Daegu, Korea, Republic of, 41944
        • Not yet recruiting
        • Kyungpook National University Hospital
        • Principal Investigator:
          • Won young Tak
        • Contact:
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Sun-jin Sym
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jihong Bae
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • Sang Cheul Oh
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yoon Namgung
        • Sub-Investigator:
          • Woojin Kim
      • Seoul, Korea, Republic of, 06351
        • Not yet recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Joon Oh Park
        • Contact:
        • Sub-Investigator:
          • Young Suk Park
        • Sub-Investigator:
          • Seung Tae Kim
        • Sub-Investigator:
          • Jung Yong Hong
      • Seoul, Korea, Republic of, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Do-Youn Oh
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 03722
        • Active, not recruiting
        • Yonsei University Health System - Severance Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Principal Investigator:
          • Hongjae Chon
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Beodeul Kang
        • Sub-Investigator:
          • Jung Sun Kim
    • Gyeongsangnam-do
      • Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
        • Recruiting
        • Gyeongsang National University Hospital
        • Principal Investigator:
          • Jung Hun Kang
        • Contact:
        • Sub-Investigator:
          • Seong Je Kim
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Principal Investigator:
          • Jun Eul Hwang
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Woo Kyun Bae
        • Sub-Investigator:
          • Hyun Jin Bang
  • Poland
      • Warszawa, Poland
        • Not yet recruiting
        • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
        • Principal Investigator:
          • Lucjan S Wyrwicz,
  • Portugal
      • Lisboa, Portugal
        • Not yet recruiting
        • Fundação Champalimaud
        • Principal Investigator:
          • Nuno Couto
      • Lisbon, Portugal
        • Not yet recruiting
        • Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
        • Principal Investigator:
          • Catarina Abreu
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clínic de Barcelona
        • Principal Investigator:
          • Alejandro Forner Gonzalez
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari Vall d´Hebron
        • Principal Investigator:
          • Teresa Macarulla Mercade
      • Cordoba, Spain
        • Not yet recruiting
        • Hospital Universitario Reina Sofa
        • Principal Investigator:
          • Rosa Maria Rodriguez Alonso,
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Principal Investigator:
          • Andres J Munoz Martin
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario 12 de octubre
        • Principal Investigator:
          • Jorge Adeva Alfonso
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
        • Principal Investigator:
          • Carmen Guillen Ponce
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Principal Investigator:
          • Angela Lamarca
      • Madrid, Spain
        • Active, not recruiting
        • Clinica Universidad de Navarra
      • Madrid, Spain
        • Active, not recruiting
        • HM Hospital Universitario Madrid Sanchinarro - CIOCC
      • Pamplona, Spain
        • Active, not recruiting
        • Clinica Universidad de Navarra
      • Santiago De Compostela, Spain
        • Not yet recruiting
        • Hospital Clinico Universitario de Santiago de Compostela
        • Principal Investigator:
          • Francisca Vazquez Rivera
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Universitario Miguel Servet
        • Principal Investigator:
          • Roberto Antonio Pazo Cid
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Not yet recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Li-Tzong Chen
        • Contact:
        • Contact:
      • Kaohsiung, Taiwan, 833401
        • Not yet recruiting
        • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
        • Principal Investigator:
          • Tai-Jan Chiu
        • Contact:
      • Taichung, Taiwan, 40705
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Teng-Yu Lee
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Chih-Hung Hsu
        • Contact:
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Ming-Huang Chen
        • Contact:
        • Contact:
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Royal Marsden Hospital NHS
        • Principal Investigator:
          • Cunningham David
      • London, United Kingdom
        • Not yet recruiting
        • UCG-1st floor central
        • Principal Investigator:
          • Bridgewater John A
      • Manchester, United Kingdom
        • Not yet recruiting
        • The Christie NHS Foundation Trust - Christie Hospital
        • Principal Investigator:
          • McNamara Mairead
      • Nottingham, United Kingdom
        • Not yet recruiting
        • Nottingham University Hospitals NHS Trust
        • Principal Investigator:
          • Arora Arvind
  • United States
    • California
      • Santa Monica, California, United States, 90401
        • Not yet recruiting
        • UCLA Medical Center
        • Principal Investigator:
          • Saeed Sadeghi
      • Stanford, California, United States, 94305
        • Active, not recruiting
        • Stanford Cancer Center
      • Westwood, California, United States, 90024
        • Recruiting
        • The University of Kansas Cancer Center
        • Principal Investigator:
          • Raed M Al-Rajabi
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Principal Investigator:
          • Mike Cusnir
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Active, not recruiting
        • The University of Chicago Hospitals
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Not yet recruiting
        • University of Michigan
        • Principal Investigator:
          • Vaibhav Sahai
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Henry Ford
        • Principal Investigator:
          • Maria Diab
    • New York
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Recruiting
        • Messino Cancer Centers
        • Principal Investigator:
          • Andrew Beardsley
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Active, not recruiting
        • University Hospitals Cleveland Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology- Nashville
        • Principal Investigator:
          • Meredith S Pelster
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Vanderbilt-Ingram Cancer Center
        • Principal Investigator:
          • Thatcher Heumann
    • Texas
      • Dallas, Texas, United States, 75201
        • Not yet recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • David Hsieh
      • Houston, Texas, United States, 77002
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Milind M Javle
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Principal Investigator:
          • Kunk Paul
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Not yet recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Alexandria T Phan

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tinengotinib 8 mg QD
Tinengotinib will be administered in 28-day cycles.
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.
Experimental: Tinengotinib 10 mg QD
Tinengotinib will be administered 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.
Active Comparator: Physician's Choice
Physician's Choice treatments include FOLFOX or FOLFIRI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Incidence, duration, and severity of adverse events (AEs)
Time Frame: Up to 30 days from study discontinuation
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
Up to 30 days from study discontinuation
Part B: PFS by BICR
Time Frame: From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.
From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: ORR by Investigator
Time Frame: Through study completion, an average of 9 months.
ORR:objective response rate (ORR), the proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Through study completion, an average of 9 months.
Part A: DOR by Investigator
Time Frame: Through study completion, an average of 9 months.
Duration of response for CR or PR based on RECIST version 1.1.
Through study completion, an average of 9 months.
Part B:Overall Survival (OS)
Time Frame: From first study drug administration until the date of death from any cause, assessed up to 24 months.
OS is defined as the time from date of randomization to date of death of any cause.
From first study drug administration until the date of death from any cause, assessed up to 24 months.
Part B: Objective Response Rate (ORR) by BICR and by Investigator:
Time Frame: Through study completion, an average of 9 months.
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Through study completion, an average of 9 months.
Part B: Duration of Response (DOR) by BICR and by Investigator
Time Frame: Through study completion, an average of 9 months.
Duration of response for CR or PR based on RECIST version 1.1.
Through study completion, an average of 9 months.
Part B: PFS by Investigators per RECIST v1.1.
Time Frame: From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TransThera Sciences (Nanjing), Inc.

Investigators

  • Principal Investigator: Milind Javle, MD, 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 Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT420C2308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangiocarcinoma

Clinical Trials on Tinengotinib 8 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe