FGFR2 Gene Fusion/RearrangementPhase 2ReFocus202NCT07359820
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
A Phase 2 study testing Lirafugratinib in people with FGFR2 Gene Fusion/Rearrangement and Other Solid Tumors, Adult, run by Elevar Therapeutics at 19 sites in 5 countries.
Trial summary
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FGFR2 Gene Fusion/Rearrangement, Other Solid Tumors, Adult
- What is being tested?
- Lirafugratinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 4 Jun 2026to Dec 2028
- Phase
- Phase 2
- 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
- Unresectable, locally advanced, or metastatic solid tumor (other than CCA).
- Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.
- Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1.
- Previously (>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies.
- Subject has not received prior treatment with an FGFRi.
Who cannot join
- An uncontrolled comorbidity.
- Patient does not have adequate organ function (defined in protocol).
- Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).
- QT interval corrected using Fridericia's formula (QTcF) > 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome.
- Clinically significant, uncontrolled cardiovascular disease.
- CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
Trial locations and contacts
19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 5 countries
United States8 sites, 8 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mass General Hospital, 877-789-6100
Andreas Varkaris, MD, PhD
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
General Office of Clinical Research, 8666706277, cancerclinicaltrials@bsd.uchicago.edu
UChicago Medicine Cancer Clinical Trials Office, 8557028222
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
UT M.D. Anderson Cancer Center Clinical Trial Information, 1-877-632-6789
Jordi Rodon Ahnert, MD, PhD
- Not yet recruiting
Mayo Clinic
Jacksonville, Florida, 32224
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Center, 800-525-2225, referapatient@mskcc.org
Alison Schram, MD
- Not yet recruiting
Mayo Clinic
Phoenix, Arizona, 85054
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Moffitt Clinical Trials Information, 1-855-470-6706
Richard Kim, MD
France4 sites, 4 recruiting
- Not yet recruiting
Institut Bergonie
Bordeaux, 33076
- Not yet recruiting
Centre Georges François Leclerc
Dijon, 21079
- Not yet recruiting
Centre Leon Berard
Lyon, 69373
- Recruiting
Gustave Roussy Cancer Campus
Paris, 94805
Department of Therapeutic Interventions and Early Trials, +33 (0)1 42 11 62 18, planificatrices.ditep@gustaveroussy.fr
Antoine Hollebecque, MD
Spain3 sites, 3 recruiting
- Recruiting
START Barcelona-Hospital HM Nou Delfos
Barcelona, 08023
START Barcelona HM Nou Delfos Facility, +34 932 54 50 30, information@startresearch.com
Tatiana Hernandez Guerrero, MD, PhD
- Recruiting
Hospital Universitario Fundación Jiménez Díaz- START MADRID
Madrid, 28040
START Madrid - FJD, +34 91 550 48 00 ext. 2805, information@startresearch.com
Manuel Pedregal Trujillo, MD
- Recruiting
Hospital Universitario HM Sanchinarro-START MADRID-CIOCC
Madrid, 28050
START Madrid - CIOCC, +34 91 756 78 25, information@startresearch.com
Juan Jose Soto Castillo, MD
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
SNUH Cancer Clinical Trials Center, +82-2-3410-6856
Do-Youn Oh, MD, PhD
- Recruiting
Samsung Medical Center
Seoul, 06351
Samsung Clinical Research Institute, +82-2-3410-6856
Joon Oh Park, MD, PhD
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
- Recruiting
The Christie NHS Foundation
Manchester, M20 4GJ
The Christie NHS Foundation Trust Cancer Information Centre, +44 161 446 3000, cancer.information@christie.nhs.uk
James Weaver, MD
About this study
Official title: A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement.
Participants will:
- Take lirafugratinib regularly as instructed by their study doctor.
- Visit the clinic as instructed for checkups and tests.
- Keep a diary recording each time a dose of lirafugratinib is taken.
- Being tested
- Lirafugratinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LirafugratinibDrug
Also called RLY-4008
Lirafugratinib is an oral inhibitor of FGFR2
| Study group | Role | What they receive |
|---|---|---|
| Lirafugratinib | Experimental | Treatment with standard dose of lirafugratinib Receives: Drug: Lirafugratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Secondary outcomes (22)
Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Number of patients with adverse events and serious adverse events.
Measured: Every cycle (4-week cycles) until study discontinuation, approximately 24 months.
Number of patients with dose interruptions.
Measured: Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose reductions.
Measured: Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose discontinuations.
Measured: Every 28-day cycle until end of treatment, approximately 24 months.
Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Duration of Response (DOR) as assessed by Investigator per RECIST v1.1.
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Progression-free survival (PFS) as assessed by Investigator and Independent Review Committee per RECIST v1.1.
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Overall survival (OS).
Measured: Up to approximately 36 months.
Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.
Measured: Up to approximately 36 months.
Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.
Measured: Up to approximately 36 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)
Measured: [Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)]
Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)
Pharmacokinetic parameters including half-life (t1/2)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)
Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
It scores (0-100) where higher means better function/quality of life in that section of the questionnaire and higher means worse symptoms in that section of the questionnaire.
Measured: Approximately every 4 weeks during treatment, approximately 24 months
Time to deterioration (TTD).
Measured: Up to approximately 36 months.
FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.
Measured: Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.
Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.
Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months
Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months
Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start4 Jun 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FGFR2 Gene Fusion/RearrangementStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elevar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359820
- Sponsor's protocol ID
- ELE-4008-202
- Acronym
- ReFocus202
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2026
- Last updated
- 3 Sep 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement
- ClinicalTrials.gov ID
- NCT07359820
- Acronym / sponsor ID
- ReFocus202 / ELE-4008-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Elevar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jan 2026 (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.
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement.
Participants will:
- Take lirafugratinib regularly as instructed by their study doctor.
- Visit the clinic as instructed for checkups and tests.
- Keep a diary recording each time a dose of lirafugratinib is taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lirafugratinib | Experimental | Drug: LirafugratinibTreatment with standard dose of lirafugratinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unresectable, locally advanced, or metastatic solid tumor (other than CCA).
- Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.
- Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1.
- Previously (>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies.
- Subject has not received prior treatment with an FGFRi.
Key exclusion criteria (6 listed)
- An uncontrolled comorbidity.
- Patient does not have adequate organ function (defined in protocol).
- Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).
- QT interval corrected using Fridericia's formula (QTcF) > 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome.
- Clinically significant, uncontrolled cardiovascular disease.
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 |
|---|---|---|
| LirafugratinibAlso: RLY-4008Lirafugratinib is an oral inhibitor of FGFR2 | Drug | Lirafugratinib |
Primary outcome
Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
22 secondary outcomes
Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Number of patients with adverse events and serious adverse events.
Time frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months.
Number of patients with dose interruptions.
Time frame: Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose reductions.
Time frame: Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose discontinuations.
Time frame: Every 28-day cycle until end of treatment, approximately 24 months.
Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Duration of Response (DOR) as assessed by Investigator per RECIST v1.1.
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Progression-free survival (PFS) as assessed by Investigator and Independent Review Committee per RECIST v1.1.
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Overall survival (OS).
Time frame: Up to approximately 36 months.
Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.
Time frame: Up to approximately 36 months.
Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.
Time frame: Up to approximately 36 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)
Time frame: [Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)]
Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)
Pharmacokinetic parameters including half-life (t1/2)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)
Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Time frame: Approximately every 4 weeks during treatment, approximately 24 months
Time to deterioration (TTD).
Time frame: Up to approximately 36 months.
FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.
Time frame: Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.
Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.
Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months
Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months
Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 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 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for FGFR2 Gene Fusion/Rearrangement
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy
Unresectable Cholangiocarcinoma, Advanced/Metastatic Cholangiocarcinoma
Active, not recruitingPhase 1
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
RecruitingPhase 2
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement
RecruitingPhase 2
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Advanced Cholangiocarcinoma, FGFR2 Fusions
RecruitingPhase 2
Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma
Biliary Tract Cancer (BTC)
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.
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lirafugratinib in people with FGFR2 Gene Fusion/Rearrangement and Other Solid Tumors, Adult, run by Elevar Therapeutics at 19 sites in 5 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, France, Spain, South Korea, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Elevar Therapeutics (+1 (385) 276-3800, info-clinicalstudy@elevartx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1. (time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.). 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 3 Sep 2026.