← Back to Search

FGFR Inhibitor

KIN-3248 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Kinnate Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you currently have cholangiocarcinoma (advanced intrahepatic or bile duct cancer), bladder cancer (advanced urothelial cancer), or any other advanced cancerous tumors?
Do you not currently have a medical condition preventing you from taking medications by mouth?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initiation of study drug through cycle 5 (up to approximately 4 months)
Awards & highlights

Study Summary

This trial will study the effects of KIN-3248, an oral small molecule that inhibits the FGFR2 and/or FGFR3 genes, in adults with advanced tumors. The trial will evaluate the safety and tolerability of the drug, as well as its preliminary efficacy.

Eligible Conditions
  • Intrahepatic Cholangiocarcinoma
  • Bladder Cancer
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have advanced bile duct or bladder cancer, or any other advanced cancer.
Select...
You are able to swallow pills or liquid medication without any medical issues.
Select...
You are not currently pregnant or breastfeeding.
Select...
You must be at least 18 years old or older than the legal age in your area.
Select...
Your tumor has a specific mutation in either the FGFR2 or FGFR3 gene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of study drug through cycle 5 (up to approximately 4 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of study drug through cycle 5 (up to approximately 4 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A (dose escalation) - incidence of adverse events (AEs)
Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR
+3 more
Secondary outcome measures
Part A (dose escalation) - PK - area under the plasma concentration-time curve (AUC) of KIN-3248
Part A (dose escalation) - PK - maximum plasma concentration (Cmax) of KIN-3248
Part A (dose escalation) - PK - time to reach maximum plasma concentration (Tmax) of KIN-3248

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B - dose expansionExperimental Treatment1 Intervention
Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A
Group II: Part A - dose escalationExperimental Treatment1 Intervention
Dose escalation of KIN-3248 in patients with solid tumors

Find a Location

Who is running the clinical trial?

Kinnate BiopharmaLead Sponsor
1 Previous Clinical Trials
400 Total Patients Enrolled

Media Library

KIN-3248 (FGFR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05242822 — Phase 1
Intrahepatic Cholangiocarcinoma Research Study Groups: Part A - dose escalation, Part B - dose expansion
Intrahepatic Cholangiocarcinoma Clinical Trial 2023: KIN-3248 Highlights & Side Effects. Trial Name: NCT05242822 — Phase 1
KIN-3248 (FGFR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05242822 — Phase 1
Intrahepatic Cholangiocarcinoma Patient Testimony for trial: Trial Name: NCT05242822 — Phase 1
~25 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top