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Clinical Trial 21518

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04913285

Phase: Phase I
Principal Investigator: Xie, Hao

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Overview

Study 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

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.

Objective

The primary objectives of the Part A Dose Escalation portion of the study are to determine the safety and tolerability of oral administration of KIN-2787 including dose-limiting toxicities (DLT) in subjects with Rapidly Accelerated Fibrosarcoma, Homolog B (BRAF) mutation positive advanced or metastatic solid tumors, to characterize the PK properties of KIN-2787, and to identify the maximum tolerated dose (MTD) and/or the appropriate dose for further clinical investigation. The primary objective of the Part B Dose Expansion portion of the study is to assess preliminary evidence of the anti-tumor activity of KIN-2787 in subjects with advanced or metastatic solid cancers that harbor either a Class II or Class III BRAF genomic alteration. The secondary objective is to characterize the PK of KIN-2787 following administration of an oral tablet formulation, including in a fed and fasted state.

Treatments

Therapies

Therapy (NOS)

Medications

Binimetinib (); KIN-2787 ()

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 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 clinically-active or clinically-progressive brain metastases from non-brain tumors.
  • 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.
  • Complete inclusion and exclusion criteria are listed in the clinical study protocol.

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