Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
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-mutated advanced or metastatic 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

Details

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.

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 KIN-2787 Dose Escalation Dose Expansion

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 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Sarah Cannon Research Institute accepting new patients
    Nashville Tennessee 37203 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kinnate Biopharma
ID
NCT04913285
Phase
Phase 1
Study Type
Interventional
Last Updated