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

NCT04913285

RecruitingPhase 1

Sponsor: Pierre Fabre Medicament

Conditions: Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma

Interventions: KIN-2787, KIN-2787 and binimetinib

Countries: United States, Australia, China, France, Italy, Spain, Taiwan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (48)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Denver, Colorado, United States
  • Jacksonville, Florida, United States
  • Orlando, Florida, United States
  • Rochester, Minnesota, United States
  • Morristown, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Fairfax, Virginia, United States
  • Waratah, New South Wales, Australia
  • Wollstonecraft, New South Wales, Australia
  • Southport, Queensland, Australia
  • Heidelberg, Victoria, Australia
  • Perth, Western Australia, Australia
  • Haerbin, Heilongjiang, China
  • Linyi, Shandong, China
  • Beijing, China
  • Shanghai, China
  • Bordeaux, France
  • Caen, France
  • Lille, France
  • Lyon, France
  • Marseille, France
  • Nantes, France
  • + 18 more on CT.gov