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Clinical Trials in the USA / NCT04913285
Recruiting Phase 1

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
No
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)

FacilityCityRegionStatus
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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First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations Recruiting
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs Recruiting
FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations Recruiting
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases Active, not recruiting

Other trials for the same condition

First In Human Study of CX-801 in Advanced Solid Tumors Recruiting
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. Active, not recruiting
A Phase 1 Study of LNCB74 in Advanced Solid Tumors Recruiting
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer Recruiting
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours Active, not recruiting
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