A Phase I/Ib 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

Study Identifier:
KN-8701
CT.gov Identifier:
NCT04913285
EudraCT Identifier:
2021-005389-16
EU Trial (CTIS) Number:
2024-516331-27-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To evaluate the safety, tolerability, pharmacokinetics and anti-cancer activity of KIN-2787 in cancer patients with mutant BRAF-driven solid tumors.

To evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF-mutated advanced or metastatic solid tumors.

Part A1 assesses single agent KIN-2787; Part A2 assesses KIN-2787 in combination w/binimetinib.

Part B will evaluate a selected dose of KIN-2787 in 3 cohorts of pts (MEL, NSCLC, or other AMST), each driven by BRAF Cl II or III alterations.

To evaluate the safety, tolerability, pharmacokinetics and antitumor activity of KIN-2787 in patients with BRAF and/or NRAS mutation-positive solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Melanoma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation Monotherapy (Part A1)
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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.
    • Willing to provide archived tumor tissue specimens obtained within the last 5 years (if available)
    • Willingness to undergo pre-treatment tumor biopsy if medically feasible.
    • According to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there must be measurable or evaluable lesions.
    • Life expectancy > 3 months.
    • QT interval (QTcF) ≤ 470 ms
    • Adequate hematology laboratory evaluation at screening
    • Perform adequate renal laboratory evaluation
    • Perform adequate liver laboratory evaluation
    • Perform adequate coagulation laboratory evaluation
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Melanoma