KIN-3248 for Intrahepatic Cholangiocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Intrahepatic Cholangiocarcinoma+3 More
KIN-3248 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Solid Tumors, Adult
  • Transitional Cell, Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Intrahepatic Cholangiocarcinoma

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: Initiation of study drug through Cycle 5 (up to approximately 4 months)

Day 28
Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)
Month 18
Part A (dose escalation) - incidence of adverse events (AEs)
Month 4
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
Month 36
Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR
Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression
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
Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression

Trial Safety

Safety Progress

1 of 3

Other trials for Intrahepatic Cholangiocarcinoma

Trial Design

2 Treatment Groups

Part A - dose escalation
1 of 2
Part B - dose expansion
1 of 2
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: KIN-3248 · No Placebo Group · Phase 1

Part A - dose escalation
Drug
Experimental Group · 1 Intervention: KIN-3248 · Intervention Types: Drug
Part B - dose expansion
Drug
Experimental Group · 1 Intervention: KIN-3248 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: initiation of study drug through cycle 5 (up to approximately 4 months)

Who is running the clinical trial?

Kinnate BiopharmaLead Sponsor
1 Previous Clinical Trials
155 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a solid tumor of the lung, stomach, colon, pancreas, kidney, or prostate.
You provide written informed consent prior to initiation of any study-specific procedures.
You have a good performance status (0 or 1).
Adequate organ function, as measured by laboratory values (criteria listed in protocol).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.