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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04913285
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pierre Fabre Medicament
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

CLaire FABRE, MD
Principal Investigator Affiliation Pierre Fabre Laboratories
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, China, France, Spain, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

This is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with BRAF mutation-positive and/or NRAS mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a RAF small molecule kinase inhibitor, to determine a recommended Phase 2 dose (RP2D) of KIN-2787, and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor. The dose expansion phase (Part B) will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers that contain BRAF Class I, II or III mutations, including lung cancer, melanoma, and other selected solid tumors.

Arms & Interventions

Arms

Experimental: Dose Escalation Monotherapy (Part A1)

Dose escalation of KIN-2787

Experimental: Dose Escalation Combination therapy (Part A2)

Dose escalation of KIN-2787 and binimetinib

Experimental: Dose Expansion Monotherapy (Part B1)

Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787

Experimental: Dose Escalation Combination therapy (Part B2)

Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib

Interventions

Drug: - KIN-2787

KIN-2787 will be administered orally twice daily in 28-day cycles

Drug: - KIN-2787 and binimetinib

Continuous and Ramp-Up cohorts: KIN-2787 (exarafenib) and binimetinib will be administered orally twice daily in 28-day cycles Intermittent Cohort: KIN-2787 will be administered orally twice daily and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSD Moores Cancer Center, La Jolla, California

Status

Recruiting

Address

UCSD Moores Cancer Center

La Jolla, California, 92093

Site Contact

Julia Appelt, CCRC

[email protected]

1-858-822-0201

UCLA, Los Angeles, California

Status

Recruiting

Address

UCLA

Los Angeles, California, 90095

Site Contact

Jessica Crocker

[email protected]

+33534506059

Stanford Cancer Center, Stanford, California

Status

Recruiting

Address

Stanford Cancer Center

Stanford, California, 94305

Site Contact

Debjani Ghoshal

[email protected]

+33534506059

Sarah Cannon Research Institute Denver, Denver, Colorado

Status

Recruiting

Address

Sarah Cannon Research Institute Denver

Denver, Colorado, 80218-1238

Site Contact

Ryan Weight, MD

[email protected]

+33534506059

Orlando, Florida

Status

Recruiting

Address

Sarah Cannon Research Institute - Florida Cancer Specialists

Orlando, Florida, 32827

NYU Langone, New York, New York

Status

Recruiting

Address

NYU Langone

New York, New York, 10016

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Michael Offin

[email protected]

+33534506059

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute-Tennessee Oncology

Nashville, Tennessee, 37203

Virginia Cancer Specialists, Fairfax, Virginia

Status

Recruiting

Address

Virginia Cancer Specialists

Fairfax, Virginia, 22031

Site Contact

Carrie Friedman, RN, BSN, OCN

[email protected]

1-703-636-1473

International Sites

Calvary Mater Hospital Newcastle, Waratah, New South Wales, Australia

Status

Recruiting

Address

Calvary Mater Hospital Newcastle

Waratah, New South Wales, 2298

Site Contact

Emily Munn

[email protected]

+61 (0)2 4014 3851

Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia

Status

Recruiting

Address

Melanoma Institute Australia

Wollstonecraft, New South Wales, 2065

Tasman Health Care, Southport, Queensland, Australia

Status

Recruiting

Address

Tasman Health Care

Southport, Queensland, 4215

Site Contact

Andrew Hill, MD

[email protected]

07 5613 2480 804

Linear Clinical Research, Perth, Western Australia, Australia

Status

Recruiting

Address

Linear Clinical Research

Perth, Western Australia, 6009

Site Contact

Michael Millward, Professor

[email protected]

(08) 6382 5100

Harbin City, Heilongjiang, China

Status

Recruiting

Address

Harbin Medical University Cancer Hospital

Harbin City, Heilongjiang, 150081

Linyi Cancer Hospital, Linyi, Shandong, China

Status

Active, not recruiting

Address

Linyi Cancer Hospital

Linyi, Shandong, 276001

Beijing University Cancer Hospital, Beijing, China

Status

Active, not recruiting

Address

Beijing University Cancer Hospital

Beijing, , 100142

The Shanghai Pulmonary Hospital, Shanghai, China

Status

Active, not recruiting

Address

The Shanghai Pulmonary Hospital

Shanghai, , 200433

Institut Bergonie, Bordeaux, France

Status

Recruiting

Address

Institut Bergonie

Bordeaux, ,

Site Contact

Antonie Italiano

[email protected]

+33 5 47 30 60 88

Centre Leon Berard, Lyon, France

Status

Recruiting

Address

Centre Leon Berard

Lyon, ,

Site Contact

Philippe Cassier

[email protected]

+33 4 26 55 68 33

APHM-CHU La Timone, Marseille, France

Status

Recruiting

Address

APHM-CHU La Timone

Marseille, ,

Site Contact

Caroline Gaudy

mailto:[email protected]

+33 (0) 4 91 38 75 94

CHU Nantes-Hotel Dieu, Nantes, France

Status

Recruiting

Address

CHU Nantes-Hotel Dieu

Nantes, ,

Site Contact

Stephanie Bordenave

[email protected]

+33 2 40 16 59 30

Gustave Roussy, Villejuif, France

Status

Recruiting

Address

Gustave Roussy

Villejuif, , 94805

Site Contact

David Planchard, MD

[email protected]

+ 33 (0)1 42 11 45 64

Hospital Quiron Dexeus, Barcelona, Spain

Status

Recruiting

Address

Hospital Quiron Dexeus

Barcelona, ,

Site Contact

María María González Cao, MD

[email protected]

+34 93 546 01 35

Las Palmas De Gran Canaria, Spain

Status

Recruiting

Address

Hospital Universitario Insular de Gran Canaria

Las Palmas De Gran Canaria, ,

Site Contact

Delvys Rodríguez

[email protected]

+34 928 44 17 38

START Madrid, Madrid, Spain

Status

Recruiting

Address

START Madrid

Madrid, , 28050

Hospital General Gregorio Marañón, Madrid, Spain

Status

Recruiting

Address

Hospital General Gregorio Marañón

Madrid, , 29009

Site Contact

Antonio Calles Blanco, MD

[email protected]

+ 34 914 26 95 16

INCLIVA (Hospital Clinico de Valencia), Valencia, Spain

Status

Recruiting

Address

INCLIVA (Hospital Clinico de Valencia)

Valencia, ,

Site Contact

Valentina Gambardella, MD

[email protected]

+34 961 97 35 31/+34 961 97 4

National Taiwan University Hospital, Taipei, Taiwan

Status

Active, not recruiting

Address

National Taiwan University Hospital

Taipei, ,

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