Solid Tumor, AdultPhase 1NCT05242822
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
A Phase 1 study testing KIN-3248 in people with Solid Tumor, Adult and Intrahepatic Cholangiocarcinoma, run by Kinnate Biopharma at 21 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma
- What is being tested?
- KIN-3248
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 29 Mar 2022to 3 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Provide written informed consent prior to initiation of any study-specific procedures
- Advanced stage solid tumor
- Known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of tumor tissue or ctDNA
- Measurable or evaluable disease according to RECIST v1.1
- ECOG performance status 0 or 1
- Adequate organ function, as measured by laboratory values (criteria listed in protocol)
- Able to swallow, retain, and absorb oral medications
Who cannot join
- Known clinically-active or clinically-progressive brain metastases from non-brain tumors
- History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic mineralization or calcification, or corneal or retinal disorder/keratopathy
- GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease
- Active, uncontrolled bacterial, fungal, or viral infection
- Women who are lactating or breastfeeding, or pregnant
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States12 sites
Massachusetts General Hospital
Boston, Massachusetts, 02214
START Midwest
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Florida
Jacksonville, Florida, 32224
UC San Diego Moores Cancer Center
La Jolla, California, 92093
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
NYU Langone Cancer Center
New York, New York, 10016
Sarah Cannon Research Institute - Lake Nona
Orlando, Florida, 32827
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
South Korea3 sites
Seoul National University Hospital (SNUH)
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03772
Samsung Medical Center
Seoul, 06351
Taiwan3 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 80756
National Taiwan University Hospital
Taipei, Taiwan, 80756
Veterans General Hospital - Taipei
Taipei, 11217
Denmark1 site
Rigshospitalet (Copenhagen University Hospital) - Finsencentret - Onkologisk Klinik
Copenhagen, 2100
About this study
Official title: A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
Read the detailed description
This is a two-part, open label, multi-center, dose escalation and dose expansion study in participants with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
Part A (dose escalation) is aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KIN-3248, and determining the maximum tolerated dose (MTD) of daily dosing of KIN-3248.
Part B (dose expansion) may open once either the MTD and/or a biologically active dose of KIN-3248 is identified. Part B is aimed at evaluating the safety and efficacy of KIN-3248 at the recommended dose and schedule in participants with cancers harboring FGFR2 and/or FGFR3 gene alterations, including intrahepatic cholangiocarcinoma (ICC), urothelial cancer (UC), and other solid tumors.
- Being tested
- KIN-3248
- Keywords
- FGFR inhibitor, targeted therapy, FGFR2 alteration, FGFR3 alteration, secondary resistance, FGFR alteration
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIN-3248Drug
KIN-3248 will be administered orally once daily in 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Part A - dose escalation | Experimental | Dose escalation of KIN-3248 in patients with solid tumors Receives: Drug: KIN-3248 |
| Part B - dose expansion | Experimental | Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A Receives: Drug: KIN-3248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Measured: Initiation of study drug through 28 days
Part A (dose escalation) - incidence of adverse events (AEs)
Measured: Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Part B (dose expansion) - objective response rate (ORR): the proportion of participants who have achieved partial response (PR) or complete response (CR) according to RECIST v1.1
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
Secondary outcomes (3)
Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248
Measured: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Part A (dose escalation) - PK - time to reach maximum plasma concentration (Tmax) of KIN-3248
Measured: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Part A (dose escalation) - PK - area under the plasma concentration-time curve (AUC) of KIN-3248
Measured: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start29 Mar 2022
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Why it stopped: Due to a change in the Sponsor's corporate strategy the study was terminated early by the Sponsor prior to enrollment into the dose expansion part of the study (Part B).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinnate Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242822
- Sponsor's protocol ID
- KN-4802
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
- ClinicalTrials.gov ID
- NCT05242822
- Acronym / sponsor ID
- KN-4802
- Keywords
- FGFR inhibitor, targeted therapy, FGFR2 alteration, FGFR3 alteration, secondary resistance, FGFR alteration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a change in the Sponsor's corporate strategy the study was terminated early by the Sponsor prior to enrollment into the dose expansion part of the study (Part B).
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kinnate BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 16 Feb 2022 (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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
Detailed description
This is a two-part, open label, multi-center, dose escalation and dose expansion study in participants with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
Part A (dose escalation) is aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KIN-3248, and determining the maximum tolerated dose (MTD) of daily dosing of KIN-3248.
Part B (dose expansion) may open once either the MTD and/or a biologically active dose of KIN-3248 is identified. Part B is aimed at evaluating the safety and efficacy of KIN-3248 at the recommended dose and schedule in participants with cancers harboring FGFR2 and/or FGFR3 gene alterations, including intrahepatic cholangiocarcinoma (ICC), urothelial cancer (UC), and other solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - dose escalation | Experimental | Drug: KIN-3248Dose escalation of KIN-3248 in patients with solid tumors |
| Part B - dose expansion | Experimental | Drug: KIN-3248Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written informed consent prior to initiation of any study-specific procedures
- Advanced stage solid tumor
- Known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of tumor tissue or ctDNA
- Measurable or evaluable disease according to RECIST v1.1
- ECOG performance status 0 or 1
Key exclusion criteria (5 listed)
- Known clinically-active or clinically-progressive brain metastases from non-brain tumors
- History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic mineralization or calcification, or corneal or retinal disorder/keratopathy
- GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease
- Active, uncontrolled bacterial, fungal, or viral infection
- Women who are lactating or breastfeeding, or pregnant
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 |
|---|---|---|
| KIN-3248KIN-3248 will be administered orally once daily in 28-day cycles | Drug | Part A - dose escalation, Part B - dose expansion |
Primary outcome
Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Time frame: Initiation of study drug through 28 days
Part A (dose escalation) - incidence of adverse events (AEs)
Time frame: Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Part B (dose expansion) - objective response rate (ORR): the proportion of participants who have achieved partial response (PR) or complete response (CR) according to RECIST v1.1
Time frame: Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR
Time frame: Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression
Time frame: Initiation of study drug until disease progression (up to approximately 36 months)
Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression
Time frame: Initiation of study drug until disease progression (up to approximately 36 months)
3 secondary outcomes
Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248
Time frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Part A (dose escalation) - PK - time to reach maximum plasma concentration (Tmax) of KIN-3248
Time frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Part A (dose escalation) - PK - area under the plasma concentration-time curve (AUC) of KIN-3248
Time frame: Initiation of study drug through Cycle 5 (up to approximately 4 months)
Results and safety
The study was stopped early (reason given: Due to a change in the Sponsor's corporate strategy the study was terminated early by the Sponsor prior to enrollment into the dose expansion part of the study (Part B).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KIN-3248 in people with Solid Tumor, Adult and Intrahepatic Cholangiocarcinoma, run by Kinnate Biopharma at 21 sites in 6 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 5 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 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, South Korea, Taiwan, China, Denmark and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to a change in the Sponsor's corporate strategy the study was terminated early by the Sponsor prior to enrollment into the dose expansion part of the study (Part B).). Results are not available in the source record.
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 (dose escalation) - incidence of dose limiting toxicities (DLTs) (time frame: Initiation of study drug through 28 days). The study lists 6 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 7 May 2025.