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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pierre Fabre Medicament
Study ID
NCT04913285
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KIN-2787 — DRUG
    KIN-2787 will be administered orally twice daily in 28-day cycles
  • KIN-2787 and binimetinib — DRUG
    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

Study Details

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.

Key Dates

First listed
Jun 4, 2021
Start date
Aug 4, 2021
Status verified
Dec 2025
Primary completion
Nov 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Part A1 Dose escalation monotherapy: [ Time Frame: Initiation of study drug through 28 days after last dose (up to approximately 18 months) ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
The Angeles ClinicLos AngelesCalifornia90025-6602
Saba Mukarram
[email protected]
310-231-2121
Omid Hamid, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Jessica Crocker
[email protected]
562-201-7669
Bartosz Chmielowski, MD (PRINCIPAL_INVESTIGATOR)
University of California San Diego, Moores Cancer CenterSan DiegoCalifornia92093
Nidhi Patel
[email protected]
1-858-822-0201
Shumei Kato, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143-2205
Michael Wong
[email protected]
415-514-6714
Adil Daud, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute DenverDenverColorado80218-1238
Josh Gordon
[email protected]
720-754-2610
Ryan Weight, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - FloridaJacksonvilleFlorida32224
Ruqin Chen, MD
[email protected]
855-776-0015
Ruqin Chen, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute - Florida Cancer SpecialistsOrlandoFlorida32827
Cesar Perez Batista, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - RochesterRochesterMinnesota55905
Arkadiusz Dudek, MD
[email protected]
855-776-0015
Arkadiusz Dudek, MD (PRINCIPAL_INVESTIGATOR)
Atlantic HealthMorristownNew Jersey07960
Salome Geene, RN
[email protected]
973-971-6373
Eric Whitman, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Kassie A. DiOrio
[email protected]
Sarah Weiss, MD (PRINCIPAL_INVESTIGATOR)
NYU LangoneNew YorkNew York10016
Janice Mehnert, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
216-444-7923
Dale Shepard, MD, PhD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute-Tennessee OncologyNashvilleTennessee37203
1(844) 482-4812
Meredith McKean, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Dahlia Mack
[email protected]
713-597-1352
Hussein Tawbi, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Carrie Friedman, RN, BSN, OCN
[email protected]
1-703-636-1473

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