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KIN-2787 + Binimetinib for Solid Tumors with BRAF and/or NRAS Mutations

Samsung Medical Center, Seoul, Korea, Republic of
Targeting 3 different conditionsKIN-2787 +1 morePhase 1RecruitingResearch Sponsored by Kinnate Biopharma

Study Summary

This trial is testing a new drug, KIN-2787, for safety and effectiveness in adults with solid tumors that have BRAF or NRAS mutations.

Eligible Conditions
  • Melanoma
  • Solid Tumors
  • Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are not currently pregnant or breastfeeding.
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You are able to take medications orally without any medical condition preventing you from doing so.
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Do you have a cancerous tumor that has spread to other parts of your body, such as lung cancer or skin cancer?
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Your cancer has a specific genetic mutation called BRAF or NRAS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initiation of study drug until disease progression (up to approximately 36 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and initiation of study drug until disease progression (up to approximately 36 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
In Part B (Dose Expansion) - disease control rate (DCR).
In Part B (Dose Expansion) - duration of overall response (DOR).
In Part B (Dose Expansion) - duration of stable disease.
+3 more
Secondary outcome measures
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to AUC.
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to Cmax.
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to tmax.
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion Monotherapy (Part B1)Experimental Treatment1 Intervention
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787
Group II: Dose Escalation Monotherapy (Part A1)Experimental Treatment1 Intervention
Dose escalation of KIN-2787
Group III: Dose Escalation Combination therapy (Part B2)Experimental Treatment1 Intervention
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib
Group IV: Dose Escalation Combination therapy (Part A2)Experimental Treatment1 Intervention
Dose escalation of KIN-2787 and binimetinib

Find a Location

Who is running the clinical trial?

Kinnate BiopharmaLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

KIN-2787 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04913285 — Phase 1
Melanoma Research Study Groups: Dose Expansion Monotherapy (Part B1), Dose Escalation Combination therapy (Part B2), Dose Escalation Monotherapy (Part A1), Dose Escalation Combination therapy (Part A2)
Melanoma Clinical Trial 2023: KIN-2787 Highlights & Side Effects. Trial Name: NCT04913285 — Phase 1
KIN-2787 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04913285 — Phase 1
Melanoma Patient Testimony for trial: Trial Name: NCT04913285 — Phase 1

Frequently Asked Questions

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

Are there numerous Canadian sites that are conducting this clinical research?

"This medical research is being conducted from 15 different sites, including Providence in Fullerton, California; Thomas Jefferson in Philadelphia, Pennsylvania, California; Thomas Jefferson in Philadelphia, Pennsylvania; and Fox Chase Cancer Center in Duarte, Florida."

Answered by AI

How many individuals are participating in the research study?

"This study necessitates the recruitment of 155 participants who meet a list of specific inclusion criteria. Those hoping to partake can do so at two sites, such as Providence in Fullerton, California and Thomas Jefferson in Philadelphia, Pennsylvania, California and Thomas Jefferson in Philadelphia, Pennsylvania."

Answered by AI

What safety concerns have been identified for KIN-2787?

"As this is a Phase 1 trial and only preliminary information about safety and efficacy exists, the rating for KIN-2787's safety was assessed as a 1."

Answered by AI

Are there opportunities available for individuals to partake in this research endeavor?

"Affirmative, clinicaltrials.gov confirms that this medical study has been actively recruiting since it was first posted on August 4th 2021. Subsequently updated on November 4th 2022, the trial is currently aiming to recruit 155 patients from 15 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Other
Nebraska
Florida
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Nebraska Cancer Specialists
Other
Sarah Cannon Research Institute - Lake Nona
Stanford Cancer Center
How many prior treatments have patients received?
3+
1
0

Why did patients apply to this trial?

Saw ad on Facebook. I saw it on Facebook. I'm hoping to find ways to mitigate skin cancers.
PatientReceived 2+ prior treatments
I don’t NOW have melanoma but had 2 in past. I’d like to know if I’m BRAF positive.
PatientReceived no prior treatments
I have failed 2 immunotherapyies, braf/mek drugs. Now I show no evidence of disease on tafinla.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Stanford Cancer Center: < 24 hours
  2. Sarah Cannon Research Institute - Lake Nona: < 48 hours
Typically responds via
Email
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
2021. "A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04913285.
All > Nebraska > Ohio
~27 spots leftby Mar 2024
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