Evaluating KIN-2787 for patients with specific tumor mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Angeles Clinic
  Los Angeles, California, United States Recruiting
• UCLA
  Los Angeles, California, United States Recruiting
• University of California San Diego, Moores Cancer Center
  San Diego, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Sarah Cannon Research Institute Denver
  Denver, Colorado, United States Recruiting
• Mayo Clinic - Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Data Protection Officer
• Email: dpofr@pierre-fabre.com
• Phone: 00 33 684752268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.