Solid Tumor MalignancyPhase 2NCT03822117
Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
A Phase 2 study testing Pemigatinib in people with Solid Tumor Malignancy, run by Incyte Corporation at 90 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancy
- What is being tested?
- Pemigatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 90 sitesin 11 countries
- Study dates
- 17 Oct 2019to 29 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
- Documentation of an FGFR1-3 gene mutation or translocation.
- Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
- Eastern Cooperative Oncology Group performance status 0 to 2.
- Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Prior receipt of a selective FGFR inhibitor in the past 6 months.
- Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
- Cannot be a candidate for potentially curative surgery.
- Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
- Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
Show all 14Show fewer
- Known additional malignancy that is progressing or requires active treatment.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
- Clinically significant or uncontrolled cardiac disease.
- Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
- Known HIV infection.
- Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
90 sites in 11 countries.
90 sites in 11 countries
United States44 sites
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Massachusetts General Hospital
Boston, Massachusetts, 02114
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28204
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke Cancer Center
Durham, North Carolina, 27710
Virginia Cancer Specialists, Pc
Fairfax, Virginia, 22031
Summit Medical Group
Florham Park, New Jersey, 07932
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, 33901
The West Clinic Pc
Germantown, Tennessee, 38138
Cancer Treatment Centers of America
Goodyear, Arizona, 85338
Cancer Institute of Greenville Health System
Greenville, South Carolina, 29605
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Indiana University Health - Arnett Cancer Care
Lafayette, Indiana, 47904
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Central Maine Medical Center
Lewiston, Maine, 04240
Joe Arrington Cancer Center
Lubbock, Texas, 79410
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Winthrop University Hospital
Mineola, New York, 11501
West Virginia University Hospitals Inc
Morgantown, West Virginia, 26506
Ochsner Clinic
New Orleans, Louisiana, 70121
Virginia Oncology Associates-Lake Wright
Norfolk, Virginia, 23502
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
Stanford Cancer Center
Palo Alto, California, 94304
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
John Wayne Cancer Institute
Santa Monica, California, 90404
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Edward H Kaplan & Associates
Skokie, Illinois, 60076
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Multicare Institute For Research & Innovation
Tacoma, Washington, 98405
Florida Cancer Specialists
Tallahassee, Florida, 32308
The University of Arizona Cancer Center
Tucson, Arizona, 85724
Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133
Carle Cancer Center
Urbana, Illinois, 61801
Florida Cancer Specialists
West Palm Beach, Florida, 33401
University of Kansas Cancer Center
Westwood, Kansas, 66205
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Umass Memorial Medical Center, Inc.
Worcester, Massachusetts, 01655
Cancer Treatment Centers of America
Zion, Illinois, 60099
Japan7 sites
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Kanazawa University Hospital
Ishikawa, 920-8641
Kobe University Hospital
Kobe, 650-0017
Tohoku University Hospital
Sendai, 980-8574
Keio University Hospital
Shinjuku-ku, 160-8582
Shizuoka Cancer Center
Shizuoka, 411-8777
Kanagawa Cancer Center
Yokohama, 241-8515
Spain7 sites
Hospital General Universitario Vall D Hebron
Barcelona, 08035
Hospital Clinic I Provincial
Barcelona, 08036
Centro Integral Oncologico Clara Campal (Ciocc)
Madrid, 28050
Hospital Regional Universitario de Malaga
Málaga, 29010
Clinica Universidad de Navarra (Cun)
Pamplona, 31008
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Universitario Y Politcnico de La Fe
Valencia, 46026
France6 sites
Institut Bergonie
Bordeaux, 33000
CENTRE GEORGES FRAN�OIS LECLERC
Dijon, 21079
Centre Antoine Lacassagne
Nice, 06189
Hospital Saint Louis
Paris, 75010
A.P.H. Paris Hopital Cochin
Paris, 75014
Institut Universitaire Du Cancer de Toulouse Oncopole
Toulouse, 31059
Italy6 sites
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
Bologna, 40138
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
Candiolo, 10060
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131
Istituto Nazionale Tumori Regina Elena Irccs
Roma, 00144
Centro Ricerche Cliniche Di Verona (Crc)
Verona, 37134
Germany5 sites
Universitatsklinikum Koln
Cologne, 50937
University Medical Center Freiburg
Freiburg im Breisgau, 79106
University Medical Centre Hamburg-Eppendorf, Centre of Oncology
Hamburg, 20246
University Hospital Grosshadern Munich
Munich, 81377
Universitaetsklinikum in Tubingen
Tübingen, 72076
Israel5 sites
Ha Emek Medical Center
Afula, 18101
Rambam Health Care Campus
Haifa, 3525408
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, 90000
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4841492
Assaf Harofeh Medical Center
Tsrifin, 7030000
South Korea4 sites
National Cancer Center
Goyang-si, 10408
Seoul National University Bundang Hospital
Seongnam-si, 13620
Severance Hospital Yonsei University Health System
Seoul, 03722
Samsung Medical Center
Seoul, 06351
United Kingdom3 sites
University College London Hospitals (Uclh)
London, NW1 2PG
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
Sarah Cannon Research Institute
London, W1G 6AD
Switzerland2 sites
Inselspital - Universitaetsspital Bern
Bern, 03010
Universitatsspital Zurich
Zurich, 08091
About this study
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.
- Conditions
- Solid Tumor Malignancy
- Being tested
- Pemigatinib
- Keywords
- Fibroblast growth factor receptor (FGFR) inhibitor, FGFR mutations, FGFR translocations, solid tumor malignancy
- Medical subject headings
- Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
Pemigatinib administered orally once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib | Experimental | Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)).
*Only FGFR fusions or rearrangements with an intact kinase domain are eligible Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
Measured: up to 483 days
ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations
Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
Measured: up to 449 days
Secondary outcomes (4)
Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).
Measured: up to 532 days
Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.
Measured: up to 24.90 months
Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Overall survival was defined as the time from the first dose of study drug to death of any cause.
Measured: up to 532 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.
Measured: up to 651 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start17 Oct 2019
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Why it stopped: A business decision was made to to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor MalignancyStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Model description
- This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Langmuir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822117
- Sponsor's protocol ID
- INCB 54828-207
- Other IDs
- 2018-004768-69, 2018
- Status last verified
- Oct 2025
- First submitted
- 28 Jan 2019
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
- Expanded access
- Available
Publications
Rodon J, Damian S, Furqan M, Garcia-Donas J, Imai H, Italiano A, Spanggaard I, Ueno M, Yokota T, Veronese ML, Oliveira N, Li X, Gilmartin A, Schaffer M, Goyal L. Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. Nat Med. 2024 Jun;30(6):1645-1654. doi: 10.1038/s41591-024-02934-7. Epub 2024 May 6.
PubMed 38710951
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
- ClinicalTrials.gov ID
- NCT03822117
- Acronym / sponsor ID
- INCB 54828-207
- Conditions
- Solid Tumor Malignancy
- Keywords
- Fibroblast growth factor receptor (FGFR) inhibitor, FGFR mutations, FGFR translocations, solid tumor malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A business decision was made to to discontinue further enrollment. There were no safety concerns that contributed to this decision.
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.
| Arm | Type | Receives |
|---|---|---|
| Pemigatinib | Experimental | Drug: PemigatinibCohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)). *Only FGFR fusions or rearrangements with an intact kinase domain are eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
- Documentation of an FGFR1-3 gene mutation or translocation.
- Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
- Eastern Cooperative Oncology Group performance status 0 to 2.
Key exclusion criteria (14 listed)
- Prior receipt of a selective FGFR inhibitor in the past 6 months.
- Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
- Cannot be a candidate for potentially curative surgery.
- Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
- Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
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 |
|---|---|---|
| PemigatinibAlso: INCB054828Pemigatinib administered orally once daily (QD). | Drug | Pemigatinib |
Primary outcome
Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Time frame: up to 483 days
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations
Time frame: up to 449 days
Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
4 secondary outcomes
Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Time frame: up to 532 days
Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Time frame: up to 24.90 months
Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Time frame: up to 532 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)
Time frame: up to 651 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38710951Rodon J, Damian S, Furqan M, Garcia-Donas J, Imai H, Italiano A, Spanggaard I, Ueno M, Yokota T, Veronese ML, Oliveira N, Li X, Gilmartin A, Schaffer M, Goyal L. Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. Nat Med. 2024 Jun;30(6):1645-1654. doi: 10.1038/s41591-024-02934-7. Epub 2024 May 6.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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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.
Peter Langmuir, MD study director
Incyte Corporation
90 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib in people with Solid Tumor Malignancy, run by Incyte Corporation at 90 sites in 11 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, Japan, Spain, France, Italy and 6 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 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?
Yes. Results are posted in the registry (first posted 15 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements (time frame: up to 483 days). 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?
On the ClinicalTrials.gov record for NCT03822117, which also lists 1 linked publication.
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 4 Nov 2025.