CholangiocarcinomaPhase 3FIRST-308NCT05948475
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
A Phase 3 study testing Tinengotinib 8 mg, Tinengotinib 10 mg and Physician's Choice in people with Cholangiocarcinoma, run by TransThera Sciences (Nanjing), Inc. at 87 sites in 13 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Tinengotinib 8 mg, Tinengotinib 10 mg and Physician's Choice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 87 sitesin 13 countries
- Study dates
- 20 Dec 2023to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
- Documentation of FGFR2 fusion/rearrangement gene status
- Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.
Who cannot join
- Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs.
- 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.
- 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.
- 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.
- Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
- 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.
- 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)
Trial locations and contacts
87 sites in 13 countries.
87 sites in 13 countries
United States19 sites
University of Michigan
Ann Arbor, Michigan, 48103
Messino Cancer Centers
Asheville, North Carolina, 28806
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
The University of Chicago Hospitals
Chicago, Illinois, 60601
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center
Dallas, Texas, 75201
Texas Oncology-Sammons Cancer Center
Dallas, Texas, 75246
Henry Ford
Detroit, Michigan, 48201
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77002
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Medical College of Wisconsin
Milwaukee, Wisconsin, 53202
University of Minnesota- Masonic Cancer Center, M Health Fairview
Minneapolis, Minnesota, 55455
Tennessee Oncology- Nashville
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
UCLA Medical Center
Santa Monica, California, 90401
Stanford Cancer Center
Stanford, California, 94305
The University of Kansas Cancer Center
Westwood, Los Angeles, California, 90024
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Italy13 sites
Clinica Oncologica, Ospedali Riuniti Umberto 1
Ancona
Candiolo Cancer Institute - FPO IRCCS
Candiolo, 10060
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
Istituto Europeo di Oncologia IRCCS
Milan
ASST Grande Ospedale Metropolitano Niguard
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples
Azienda Ospedaliera Universitaria di Parma
Parma
Azienda Ospedaliero-Universitaria Pisana
Pisa
Humanitas Research Hospital
Rozzano
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena
AOUI Verona - Ospedale Borgo Roma
Verona
Spain12 sites
Hospital Clínic de Barcelona
Barcelona
Hospital Universitari Vall d´Hebron
Barcelona
Hospital Universitario Reina Sofa
Córdoba
Clinica Universidad de Navarra
Madrid
HM Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Clinica Universidad de Navarra
Pamplona
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Universitario Miguel Servet
Zaragoza
South Korea11 sites
Inje University Haeundae Paik Hospital
Busan, 48108
Dong-A University Hospital
Busan, 49201
Kyungpook National University Hospital
Daegu, 41944
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Gachon University Gil Medical Center
Incheon, 21565
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Seoul National University Hospital
Seoul, 03080
Yonsei University Health System - Severance Hospital
Seoul, 03722
Samsung Medical Center
Seoul, 06351
Korea University Guro Hospital
Seoul, 08308
France8 sites
Institut Sainte Catherine - Institut du Cancer Avignon Provence
Avignon
Centre Hospitalier Régional Universitaire de Besançon
Besançon
Hopital Beaujon
Clichy
Hopital Franco-Britannique - Fondation Cognacq-Jay
Levallois-Perret
Clinique de la Sauvegarde
Lyon
Centre Hospitalier Universitaire de Montpellier
Montpellier
Hopital Saint Antoine
Paris
Institut de Cancerologie Gustave Roussy
Villejuif
Germany6 sites
Krebszentrum Reutlingen
Baden
Krankenhaus Nordwest gGmbH
Frankfurt
Asklepios Klinik Altona
Hamburg
Medizinische Hochschule Hannover
Hanover
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)
Heidelberg
Ludwig-Maximilians-Universität München Kum
München
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Kaohsiung City, 833401
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
United Kingdom4 sites
Royal Marsden Hospital NHS
London
UCG-1st floor central
London
The Christie NHS Foundation Trust - Christie Hospital
Manchester
Nottingham University Hospitals NHS Trust
Nottingham
Belgium3 sites
Universitair Ziekenhuis Antwerpen
Antwerp
Universitair Ziekenhuis Gent
Ghent
Universitair Ziekenhuis Leuven
Leuven
Austria2 sites
Ordensklinikum Linz GmbH
Linz
Landesklinikum Wiener Neustadt
Wiener Neustadt
Portugal2 sites
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
Lisbon
Fundação Champalimaud
Lisbon
About this study
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
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
Read the 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- Tinengotinib 8 mg, Tinengotinib 10 mg, Physician's Choice
- Keywords
- Refractory/Relapsed Cholangiocarcinoma
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinengotinib 8 mgDrug
Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.
Tinengotinib 10 mgDrug
Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.
Physician's ChoiceDrug
For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Tinengotinib 8 mg QD | Experimental | Tinengotinib will be administered in 28-day cycles. Receives: Drug: Tinengotinib 8 mg |
| Tinengotinib 10 mg QD | Experimental | Tinengotinib will be administered in 28-day cycles. Receives: Drug: Tinengotinib 10 mg |
| Physician's Choice | Active comparator | Physician's Choice treatments include FOLFOX or FOLFIRI Receives: Drug: Physician's Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Incidence, duration, and severity of adverse events (AEs)
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
Measured: Up to 30 days from study discontinuation
Part B: PFS by BICR
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.
Measured: 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 outcomes (6)
Part A: ORR by Investigator
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.
Measured: Through study completion, an average of 9 months.
Part A: DOR by Investigator
Duration of response for CR or PR based on RECIST version 1.1.
Measured: Through study completion, an average of 9 months.
Part B:Overall Survival (OS)
OS is defined as the time from date of randomization to date of death of any cause.
Measured: 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:
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Measured: Through study completion, an average of 9 months.
Part B: Duration of Response (DOR) by BICR and by Investigator
Duration of response for CR or PR based on RECIST version 1.1.
Measured: Through study completion, an average of 9 months.
Part B: PFS by Investigators per RECIST v1.1.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start20 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milind Javle, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948475
- Sponsor's protocol ID
- TT420C2308
- Acronym
- FIRST-308
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05948475
- Acronym / sponsor ID
- FIRST-308 / TT420C2308
- Conditions
- Cholangiocarcinoma
- Keywords
- Refractory/Relapsed Cholangiocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tinengotinib 8 mg QD | Experimental | Drug: Tinengotinib 8 mgTinengotinib will be administered in 28-day cycles. |
| Tinengotinib 10 mg QD | Experimental | Drug: Tinengotinib 10 mgTinengotinib will be administered in 28-day cycles. |
| Physician's Choice | Active comparator | Drug: Physician's ChoicePhysician's Choice treatments include FOLFOX or FOLFIRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
- Documentation of FGFR2 fusion/rearrangement gene status
- Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.
Key exclusion criteria (7 listed)
- Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs.
- 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.
- 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.
- 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.
- Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinengotinib 8 mgSubjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles. | Drug | Tinengotinib 8 mg QD |
| Tinengotinib 10 mgSubjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles. | Drug | Tinengotinib 10 mg QD |
| Physician's ChoiceFor subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle. | Drug | Physician's Choice |
Primary outcome
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).
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.
6 secondary outcomes
Part A: ORR by Investigator
Time frame: Through study completion, an average of 9 months.
Part A: DOR by Investigator
Time frame: 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.
Part B: Objective Response Rate (ORR) by BICR and by Investigator:
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milind Javle, MD principal investigator
M.D. Anderson Cancer Center
87 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tinengotinib 8 mg, Tinengotinib 10 mg and Physician's Choice in people with Cholangiocarcinoma, run by TransThera Sciences (Nanjing), Inc. at 87 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Italy, Spain, South Korea, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Incidence, duration, and severity of adverse events (AEs) (time frame: Up to 30 days from study discontinuation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.