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

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.

Conditions

Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma

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Study Overview

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Study Details

Study overview

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.

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.

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Fullerton

Providence, Fullerton, California, United States, 92835

La Jolla

UCSD Moores Cancer Center, La Jolla, California, United States, 92093

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Sacramento

UC Davis, Sacramento, California, United States, 95817

Santa Rosa

Providence Medical Foundation (St. Joseph's), Santa Rosa, California, United States, 95403

Stanford

Stanford Cancer Center, Stanford, California, United States, 94305

Orlando

Orlando Health Cancer Institute, Orlando, Florida, United States, 32806

Orlando

Sarah Cannon Research Institute - Lake Nona, Orlando, Florida, United States, 32827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pierre Fabre Medicament,

CLaire FABRE, MD, STUDY_CHAIR, Pierre Fabre Laboratories

Study Record Dates

2025-12