Tests KIN-2787 in adults with BRAF or NRAS mutated solid tumors
Tests the drug KIN-2787, alone or with binimetinib, in adults with advanced tumors.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Key facts
- Where
- Naples, ItalySee the site
- Phase
- Phase 1
Where in Italy
- Istituto Nazionale dei Tumori Fondazione G. PascaleNaples, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pierre Fabre Medicament
- Trial code
- NCT04913285
- Record updated
- 2 September 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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: 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; 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; 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.