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 is this study for? Adult patients with BRAF-Mutated Solid Tumors
What treatments are being studied? KIN-2787
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
The Angeles Clinic
RECRUITING
Los Angeles
UCLA
RECRUITING
Los Angeles
University of California San Diego, Moores Cancer Center
RECRUITING
San Diego
University of California San Francisco
RECRUITING
San Francisco
Stanford Cancer Center
RECRUITING
Stanford
Colorado
Sarah Cannon Research Institute Denver
RECRUITING
Denver
Florida
Sarah Cannon Research Institute - Florida Cancer Specialists
RECRUITING
Orlando
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYU Langone
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Tennessee
Sarah Cannon Research Institute-Tennessee Oncology
RECRUITING
Nashville
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Australia
Linear Clinical Research
RECRUITING
Perth
Tasman Health Care
RECRUITING
Southport
Calvary Mater Hospital Newcastle
RECRUITING
Waratah
Melanoma Institute Australia
RECRUITING
Wollstonecraft
China
Beijing University Cancer Hospital
ACTIVE_NOT_RECRUITING
Beijing
Harbin Medical University Cancer Hospital
RECRUITING
Haerbin
Linyi Cancer Hospital
ACTIVE_NOT_RECRUITING
Linyi
The Shanghai Pulmonary Hospital
ACTIVE_NOT_RECRUITING
Shanghai
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
APHM-CHU La Timone
RECRUITING
Marseille
CHU Nantes-Hotel Dieu
RECRUITING
Nantes
Gustave Roussy
RECRUITING
Villejuif
Spain
Arance
RECRUITING
Barcelona
Hospital Quiron Dexeus
RECRUITING
Barcelona
Hospital Universitario Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital General Gregorio Marañón
RECRUITING
Madrid
NEXT Quirónsalud Madrid
RECRUITING
Madrid
START Madrid
RECRUITING
Madrid
H. Regional de Málaga
RECRUITING
Málaga
H. Virgen Macarena
RECRUITING
Seville
Berrocal
RECRUITING
Valencia
INCLIVA (Hospital Clinico de Valencia)
RECRUITING
Valencia
Taiwan
National Taiwan University Hospital
ACTIVE_NOT_RECRUITING
Taipei
Contact Information
Primary
Claire Fabre, MD
claire.fabre@pierre-fabre.com
+33534506059
Backup
Moutaffian Helene, PhD
helene.moutaffian@pierre-fabre.com
+33772344986
Time Frame
Start Date: 2021-08-04
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 400
Treatments
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
Authors
Related Therapeutic Areas
Sponsors
Leads: Pierre Fabre Medicament