Clinical Trials /

A Study to Evaluate KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors

NCT04913285

Description:

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF-mutated advanced or metastatic solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors
  • Official Title: A Phase 1/1b Open-Label, Multicenter, Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: KN-8701
  • NCT ID: NCT04913285

Conditions

  • Solid Tumor, Adult
  • Non-small Cell Lung Cancer
  • Melanoma

Interventions

DrugSynonymsArms
KIN-2787Dose Escalation

Purpose

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF-mutated advanced or metastatic solid tumors.

Detailed Description

      BRAF, a gene that helps to control cell growth, is commonly altered in some cancers. BRAF
      alterations can be categorized into three classes based on their unique properties. Targeted
      therapies have been approved to treat certain types of cancers that harbor BRAF Class I
      mutations. However, there are currently no approved BRAF targeted therapies available for
      patients with tumors driven by Class II or Class III BRAF alterations

      This study will evaluate the safety, pharmacokinetics (PK), and early clinical activity of
      KIN-2787, an experimental drug intended to target solid tumors harboring Class I, Class II,
      or Class III BRAF alterations.
    

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalDose escalation of KIN-2787 in patients with solid tumors harboring Class I, Class II, or Class III BRAF alterations
  • KIN-2787
Dose ExpansionExperimentalDose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 in patients with NSCLC, melanoma, and other solid tumors harboring Class II or Class III BRAF alterations
  • KIN-2787

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 as confirmed by previous genomic
             analysis of tumor tissue or ctDNA.

          -  Must have received prior standard therapy appropriate for the tumor type and stage of
             disease (including prior therapy with a BRAF inhibitor if FDA approved for the cancer
             type), OR unlikely to tolerate or derive clinically meaningful benefit from
             appropriate standard of care therapy.

          -  Measurable or evaluable disease by RECIST v1.1.

          -  ECOG performance status 0, 1, or 2.

          -  Adequate organ function, as measured by laboratory values (criteria listed in
             protocol).

          -  Able to swallow, retain, and absorb oral medications.

        Exclusion Criteria:

          -  Known active brain metastases from non-brain tumors.

          -  For tumor types and indications not approved by FDA, prior receipt of any 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.

          -  Seropositive for hepatitis B or hepatitis C.

          -  Women who are lactating or breastfeeding, or pregnant.

          -  In Dose Expansion, patients with BRAF Class I mutations are excluded.

        Complete inclusion and exclusion criteria are listed in the clinical study protocol.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and incidence of clinically significant changes in vital signs, physical examinations, ECGs, and clinical laboratory tests.
Time Frame:Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Safety Issue:
Description:Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression

Secondary Outcome Measures

Measure:Maximum observed plasma concentration (Cmax) of KIN-2787
Time Frame:Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Safety Issue:
Description:
Measure:Time to achieve Cmax (Tmax)
Time Frame:Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Safety Issue:
Description:
Measure:Area under the plasma concentration-time curve (AUC).
Time Frame:Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kinnate Biopharma

Trial Keywords

  • 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

Last Updated

August 18, 2021