RecruitingPhase 1

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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests KIN-2787 in adults with solid tumors that are advanced or have spread and have certain BRAF or NRAS gene changes. It checks the drug’s safety, side effects, how the body handles it, and early signs of whether it works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before any study procedures.
  • Have a solid tumor that is advanced or has spread.
  • Have a BRAF Class I, II, or III gene change, or melanoma (a skin cancer) with an NRAS gene change, confirmed by earlier tumor or blood testing.
  • Have cancer that can be measured for Parts A and B, or otherwise checked for Part A, using standard study rules.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have organs that work well enough based on lab tests.
  • Be able to swallow, keep down, and absorb medicine taken by mouth.

Who can't join

  • Have had surgery or radiation aimed at a specific tumor area. This rule is unclear in the listing; ask the study team. Some people with untreated cancer in the brain and no symptoms may qualify.
  • For Part B, have had certain drugs that target BRAF, MEK, or MAPK, whether approved or still being tested.
  • Have digestive tract disease that prevents taking or absorbing pills, need feeding through a vein, or have uncontrolled swelling in the digestive tract.
  • Have an active bacterial, fungal, or viral infection that is not controlled.
  • Have a positive COVID-19 test, a known infection even without symptoms, or a suspected infection.
  • Be pregnant or producing breast milk, including breastfeeding.
  • Have had another active cancer treated within the past 3 years.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (15)

CA

CO

FL

MN

NJ

NY

  • NYU Langone · New York, NY 10016CT.gov@nyulangone.org · Study contactJanice Mehnert, MD · Principal investigatorMore trials in New York

OH

TN

TX

VA