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

RecruitingPhase 1

A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants With BRAF and/or NRAS Mutation-positive Solid Tumors.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Pierre Fabre Medicament · Participants: 400 · Started: Aug 4, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04913285

Locations in the U.S.

CaliforniaThe Angeles Clinic, Los Angeles
UCLA, Los Angeles
University of California San Diego, Moores Cancer Center, San Diego
University of California San Francisco, San Francisco
ColoradoSarah Cannon Research Institute Denver, Denver
FloridaMayo Clinic - Florida, Jacksonville
Sarah Cannon Research Institute - Florida Cancer Specialists, Orlando
MinnesotaMayo Clinic - Rochester, Rochester
New JerseyAtlantic Health, Morristown
Rutgers Cancer Institute of New Jersey, New Brunswick
New YorkNYU Langone, New York
OhioCleveland Clinic, Cleveland
TennesseeSarah Cannon Research Institute-Tennessee Oncology, Nashville
TexasMD Anderson, Houston (Not yet recruiting)
VirginiaVirginia Cancer Specialists, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.