A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
Purpose
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
- Solid Tumor, Adult
- Intrahepatic Cholangiocarcinoma
- Urothelial Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A - dose escalation |
Dose escalation of KIN-3248 in patients with solid tumors |
|
|
Experimental Part B - dose expansion |
Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A |
|
More Details
- Status
- Terminated
- Sponsor
- Kinnate Biopharma
Study Contact
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.