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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
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You have advanced bile duct or bladder cancer, or any other advanced cancer.
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You are able to swallow pills or liquid medication without any medical issues.
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You are not currently pregnant or breastfeeding.
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You must be at least 18 years old or older than the legal age in your area.
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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of individuals participating in this trial?

"Kinnate Biopharma are recruiting 120 eligible patients to carry out the trial. Two of their participating locations include Mayo Clinic Arizona in Phoenix, Arizona and UC San Diego Moores Cancer Center in La Jolla, California."

Answered by AI

Are there multiple sites in this state that are conducting the trial?

"Aside from Mayo Clinic Arizona in Phoenix, AZ and UC San Diego Moores Cancer Center in La Jolla, CA as well as Mayo Clinic Florida in Jacksonville, FL this clinical trial is also running out of 8 other sites."

Answered by AI

Has the FDA sanctioned KIN-3248 for therapeutic use?

"KIN-3248's safety is ranked a 1 since this is an early Phase 1 trial, meaning there are only a few studies attesting to its efficacy and protective properties."

Answered by AI

Is it possible to register for this research endeavor?

"According to the clinicaltrials.gov database, this research project is in active search for study participants. Initially posted on April 18th 2022 and recently updated November 7th 2022, it remains open to new enrollees."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Florida
Other
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
2
0
What site did they apply to?
Sarah Cannon Research Institute - Lake Nona
Mayo Clinic Florida
Other
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Why did patients apply to this trial?

Tumor is about timing. I need something to work. Chemo, radiation, afatinib.
PatientReceived 2+ prior treatments
I have different treatments but any one offer me a cure. I am not sure what this trial is for I was just looking for a trial.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Do you look at people like me who have a solid tumor on my pancreas?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Johns Hopkins Sidney Kimmel Comprehensive Cancer Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
2022. "A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05242822.
~28 spots leftby Jun 2026
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