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Evaluating KIN-2787 for patients with specific tumor mutations

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.

Phase 1 Interventional Pierre Fabre Medicament · NCT04913285

This study is testing a new drug called KIN-2787 to see if it can help adults with advanced cancers that have certain gene mutations, like those found in lung cancer and melanoma.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorPierre Fabre Medicament Industry-sponsored
Drugs / interventionsradiation, binimetinib
Locations29 sites (La Jolla, California and 28 other locations)
Trial IDNCT04913285 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-2787, a RAF small molecule kinase inhibitor, in adults with advanced or metastatic solid tumors that have BRAF or NRAS mutations. It consists of two parts: a dose escalation phase to determine the recommended Phase 2 dose and a dose expansion phase to evaluate the drug's effectiveness in patients with specific types of cancer, including lung cancer and melanoma. Participants will receive KIN-2787 alone or in combination with binimetinib, a MEK inhibitor, to understand the potential benefits of this treatment approach.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors that have confirmed BRAF Class I, II, or III mutations or NRAS mutations.

Not a fit: Patients who have previously received treatment with small molecule BRAF, MEK, or MAPK inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with BRAF or NRAS mutation-positive solid tumors.

How similar studies have performed: Other studies have shown promise with similar approaches targeting BRAF and NRAS mutations, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

La Jolla, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumor, AdultNon-small Cell Lung CancerMelanomaBRAF inhibitorBRAFpan-RAFpan-RAF inhibitorRAF1
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.