Clinical trial · Interventional
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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).
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KIN-3248 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A - dose escalation
- description
- Dose escalation of KIN-3248 in patients with solid tumors
- interventionNames
- Drug: KIN-3248
- type
- EXPERIMENTAL
- label
- Part B - dose expansion
- description
- Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A
- interventionNames
- Drug: KIN-3248
Primary outcomes (6)
- measure
- Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
- timeFrame
- Initiation of study drug through 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available