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KN-8701

A study to evaluate kin-2787 in participants with braf and/or nras mutation positive solid tumors
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT04913285
BRAF inhibitor
BRAF
pan-RAF
pan-RAF inhibitor
RAF1
ARAF
BRAF alteration
BRAF Class II
BRAF Class III
V600
tumor growth inhibitor (TGI)
melanoma
NSCLC
solid tumor
targeted therapy
BRAF Class I
NRAS
Metastatic
Unresectable
CRC
ATC
Colon
Thyroid
Advanced
Exarafenib
binimetinib
Source : Importé depuis le centre
Recrutement partiellement ouvert
Dernière modification : 2025/03/02
Type de recherche

Interventionnel

Médicament expérimental

PHASE1


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

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.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Dose Escalation Monotherapy (Part A1) Dose escalation of KIN-2787 Donnée non disponible
  • Inconnu
  • Dose Escalation Combination therapy (Part A2) Dose escalation of KIN-2787 and binimetinib Donnée non disponible
  • Inconnu
  • Dose Expansion Monotherapy (Part B1) Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 Donnée non disponible
  • Inconnu
  • Dose Escalation Combination therapy (Part B2) Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib Donnée non disponible
  • Inconnu
  • Dose Escalation Monotherapy (Part A1)
    État du recrutement
    unknown
    Dose Escalation Combination therapy (Part A2)
    État du recrutement
    unknown
    Dose Expansion Monotherapy (Part B1)
    État du recrutement
    unknown
    Dose Escalation Combination therapy (Part B2)
    État du recrutement
    unknown
    Données à jour depuis : 2 mars 2025

    Description de l'étude

    Résumé de l'étude

    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.

    Source : Importé depuis le centre

    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.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 2 mars 2025
    Données à jour depuis : 4 mars
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT04913285