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.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, China, France, Korea, Republic of, Netherlands, 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

KIN-2787 and binimetinib will be administered orally twice daily in 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.

City of Hope, Duarte, California

Status

Completed

Address

City of Hope

Duarte, California, 91010

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