ACTIVE_NOT_RECRUITING

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

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Conditions

Solid Tumor, AdultNon-small Cell Lung CancerMelanomaBRAF inhibitorBRAFpan-RAFpan-RAF inhibitorRAF1ARAFBRAF alterationBRAF Class IIBRAF Class IIIV600tumor growth inhibitor (TGI)NSCLCsolid tumortargeted therapyBRAF Class INRASMetastaticUnresectableCRCATCColonThyroidAdvancedExarafenibbinimetinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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.

Quick Facts

Study Start:2021-08-04
Study Completion:2029-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04913285

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide written informed consent prior to initiation of any study-specific procedures.
  2. * Metastatic or advanced stage solid tumor
  3. * 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.
  4. * Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.
  5. * ECOG performance status 0-1
  6. * Adequate organ function, as measured by laboratory values (criteria listed in protocol).
  7. * Able to swallow, retain, and absorb oral medications.
  1. * 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)
  2. * In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.
  3. * GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.
  4. * Active, uncontrolled bacterial, fungal, or viral infection.
  5. * 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
  6. * Women who are lactating or breastfeeding, or pregnant.
  7. * Participants with any other active treated malignancy within 3 years prior to enrollment

Contacts and Locations

Principal Investigator

CLaire FABRE, MD
STUDY_CHAIR
Pierre Fabre Laboratories

Study Locations (Sites)

The Angeles Clinic
Los Angeles, California, 90025-6602
United States
UCLA
Los Angeles, California, 90095
United States
University of California San Diego, Moores Cancer Center
San Diego, California, 92093
United States
University of California San Francisco
San Francisco, California, 94143-2205
United States
Stanford Cancer Center
Stanford, California, 94305
United States
Sarah Cannon Research Institute Denver
Denver, Colorado, 80218-1238
United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224
United States
Sarah Cannon Research Institute - Florida Cancer Specialists
Orlando, Florida, 32827
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Atlantic Health
Morristown, New Jersey, 07960
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
NYU Langone
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Sarah Cannon Research Institute-Tennessee Oncology
Nashville, Tennessee, 37203
United States
MD Anderson
Houston, Texas, 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Pierre Fabre Medicament

  • CLaire FABRE, MD, STUDY_CHAIR, Pierre Fabre Laboratories

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-04
Study Completion Date2029-03-30

Study Record Updates

Study Start Date2021-08-04
Study Completion Date2029-03-30

Terms related to this study

Keywords Provided by Researchers

  • BRAF inhibitor
  • BRAF
  • pan-RAF
  • pan-RAF inhibitor
  • RAF1
  • ARAF
  • BRAF alteration
  • BRAF Class II
  • BRAF Class III
  • V600
  • tumor growth inhibitor (TGI)
  • melanoma
  • NSCLC
  • solid tumor
  • targeted therapy
  • BRAF Class I
  • NRAS
  • Metastatic
  • Unresectable
  • CRC
  • ATC
  • Colon
  • Thyroid
  • Advanced
  • Exarafenib
  • binimetinib

Additional Relevant MeSH Terms

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