A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 G… (NCT05242822) | Clinical Trial Compass
TerminatedPhase 1
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
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).
United States, China, Denmark54 participantsStarted 2022-03-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Timeframe: Initiation of study drug through 28 days
2
Part A (dose escalation) - incidence of adverse events (AEs)
Timeframe: Initiation of study drug through 28 days after last dose (up to approximately 18 months)
3
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
Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)
4
Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR
Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)
5
Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression
Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)
6
Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression