Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 1/1b 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.

Details

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 II or III mutations, including lung cancer, melanoma, and other selected solid tumors.

Keywords

Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma, BRAF inhibitor, BRAF, pan-RAF, pan-RAF inhibitor, RAF1, ARAF, BRAF alteration, BRAF Class II, BRAF Class III, V600, tumor growth inhibitor (TGI), NSCLC, solid tumor, targeted therapy, BRAF Class I, NRAS, Metastatic, Unresectable, CRC, ATC, Colon, Thyroid, Advanced, KIN-2787, KIN-2787 and binimetinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.
  • In Part B Dose Expansion, patients with BRAF Class I mutations are excluded.
  • 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

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Providence not yet accepting patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kinnate Biopharma
ID
NCT04913285
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 155 study participants
Last Updated