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

Running, not enrolling · Phase 1

Conditions studied: Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma

In brief

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.

Key facts

Study ID

NCT04913285

Run by

Pierre Fabre Medicament

People needed

400

Starts

2021-08-04

Expected to finish

2029-03-30

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Angeles Clinic — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• University of California San Diego, Moores Cancer Center — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Sarah Cannon Research Institute Denver — Denver, Colorado, United States
• Mayo Clinic - Florida — Jacksonville, Florida, United States
• Sarah Cannon Research Institute - Florida Cancer Specialists — Orlando, Florida, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Atlantic Health — Morristown, New Jersey, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• NYU Langone — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Sarah Cannon Research Institute-Tennessee Oncology — Nashville, Tennessee, United States
• MD Anderson — Houston, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Calvary Mater Hospital Newcastle — Waratah, New South Wales, Australia
• Melanoma Institute Australia — Wollstonecraft, New South Wales, Australia
• Tasman Health Care — Southport, Queensland, Australia
• Austin Health — Heidelberg, Victoria, Australia
• Linear Clinical Research — Perth, Western Australia, Australia
• Harbin Medical University Cancer Hospital — Haerbin, Heilongjiang, China
• Linyi Cancer Hospital — Linyi, Shandong, China
• Beijing University Cancer Hospital — Beijing, China

Full record on ClinicalTrials.gov

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