A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

NCT04913285 · tracked via the Priya Life Science USA tracker

Sponsor

Pierre Fabre Medicament

Phase

Phase 1

Started

2021-08-04

Last updated

2026-09-02

Condition(s) studied

Solid Tumor, AdultNon-small Cell Lung CancerMelanoma

Investigational drug(s) / intervention(s)

KIN-2787KIN-2787 and binimetinib

KIN-2787: KIN-2787 will be administered orally twice daily in 28-day cycles

KIN-2787 and binimetinib: Continuous and Ramp-Up cohorts: KIN-2787 (exarafenib) and binimetinib will be administered orally twice daily in 28-day cycles Intermittent Cohort: KIN-2787 will be administered orally twice daily and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles

Study summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Provide written informed consent prior to initiation of any study-specific procedures. * Metastatic or advanced stage solid tumor * Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS mutation as confirmed by previous genomic analysis of tumor tissue or ctDNA. * Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1. * ECOG performance status 0-1 * Adequate organ function, as measured by laboratory values (criteria listed in protocol). * Able to swallow, retain, and absorb oral medications. Exclusion Criteria: * Known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain metastasis may be eligible if met with certain criteria) * In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy. * 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. * Participant with a positive test result for SARS-CoV2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV2, is excluded * Women who are lactating or breastfeeding, or pregnant. * Participants with any other active treated malignancy within 3 years prior to enrollment Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Primary outcome measure(s)

Part A1 Dose escalation monotherapy: — Initiation of study drug through 28 days after last dose (up to approximately 18 months)
To determine the safety and tolerability of oral administration of KIN-2787 including dose-limiting toxicities (DLTs), and to identify the maximum tolerated dose (MTD) and/or the appropriate dose for further clinical investigation in Part B Dose Expansion.
Part A2 Dose Escalation: KIN-2787 + Binimetinib Combination — Initiation of study drug through 28 days after last dose (up to approximately 18 months)
To determine the safety and tolerability of oral administration of KIN-2787 + binimetinib including DLTs, and to identify the MTD and/or the appropriate dose for further clinical investigation.
In Part B (Dose Expansion) - objective response rate (ORR) using RECIST v1.1. — Initiation of study drug until disease progression (up to approximately 36 months)
To assess preliminary evidence of the anti-cancer activity of KIN-2787 and for (B2) KIN-2787 + binimetinib
In Part B (Dose Expansion) - disease control rate (DCR). — Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - duration of overall response (DOR). — Initiation of study drug until disease progression (up to approximately 36 months)
Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression
In Part B (Dose Expansion) - duration of stable disease. — Initiation of study drug until disease progression (up to approximately 36 months)

Trial sites (48)

Facility	City	Region	Status
The Angeles Clinic	Los Angeles	California	Recruiting
UCLA	Los Angeles	California	Recruiting
University of California San Diego, Moores Cancer Center	San Diego	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
Sarah Cannon Research Institute Denver	Denver	Colorado	Recruiting
Mayo Clinic - Florida	Jacksonville	Florida	Recruiting
Sarah Cannon Research Institute - Florida Cancer Specialists	Orlando	Florida	Recruiting
Mayo Clinic - Rochester	Rochester	Minnesota	Recruiting
Atlantic Health	Morristown	New Jersey	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	Recruiting
NYU Langone	New York	New York	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
Sarah Cannon Research Institute-Tennessee Oncology	Nashville	Tennessee	Recruiting
MD Anderson	Houston	Texas	Not Yet Recruiting
Virginia Cancer Specialists	Fairfax	Virginia	Recruiting
Calvary Mater Hospital Newcastle	Waratah	New South Wales	Recruiting
Melanoma Institute Australia	Wollstonecraft	New South Wales	Recruiting
Tasman Health Care	Southport	Queensland	Recruiting
Austin Health	Heidelberg	Victoria	Recruiting
Linear Clinical Research	Perth	Western Australia	Recruiting
Harbin Medical University Cancer Hospital	Haerbin	Heilongjiang	Recruiting
Linyi Cancer Hospital	Linyi	Shandong	Active Not Recruiting
Beijing University Cancer Hospital	Beijing	China	Active Not Recruiting
The Shanghai Pulmonary Hospital	Shanghai	China	Active Not Recruiting
Institut Bergonie	Bordeaux	France	Recruiting
Centre Francois Baclesse	Caen	France	Recruiting
CHU de Lille	Lille	France	Recruiting
Centre Leon Berard	Lyon	France	Recruiting
APHM-CHU La Timone	Marseille	France	Recruiting
CHU Nantes-Hotel Dieu	Nantes	France	Recruiting
CHU de Nice - Hôpital Archet 2	Nice	France	Recruiting
APHP - Hôpital St Louis	Paris	France	Recruiting
Hospices Civiles de Lyon - Hôpital Lyon Sud	Pierre-Bénite	France	Recruiting
CHU de Poitiers	Poitiers	France	Recruiting
Oncopole Claudius Regaud	Toulouse	France	Recruiting
Gustave Roussy	Villejuif	France	Recruiting
Istituto Nazionale dei Tumori Fondazione G. Pascale	Naples	Italy	Recruiting
Arance	Barcelona	Spain	Recruiting
NEXT Quirónsalud Madrid	Madrid	Spain	Recruiting
H. Regional de Málaga	Málaga	Spain	Recruiting

+ 8 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04913285 on ClinicalTrials.gov ↗ ← All trials in the USA