Clinical Trial 24103

• Overview

  Study Title:

  A First-in-Human Phase 1 Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation

  Summary:

  The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally to adults with advanced or metastatic solid tumors with certain KRAS mutations.

  Objective:

  Primary objective: * To characterize the safety and tolerability of KST-6051 and to estimate the RDE(s) in participants with advanced or metastatic solid tumors with a KRAS mutation Secondary objectives: * To evaluate the PK of KST-6051 after administration as an oral tablet formulation * To evaluate preliminary activity of KST-6051 in participants with advanced or metastatic solid tumors with a KRAS mutation

• Treatments

  Therapies:

  pan-KRAS inhibitor

  Medications:

  KST-6051 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Age ≥ 18 years.
  • Willing and able to give written informed consent.
  • Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor.
  • Documentation of KRAS mutation prior to the first dose of trial drug(s).
  • Progressed on or intolerant to standard treatment(s).
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Adequate cardiovascular, hematological, liver, and renal function.
  • Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).

• Exclusion Criteria

  Key Exclusion Criteria:
  • Previous or current treatment with RAS or KRAS inhibitors.
  • Central nervous system (CNS) tumors or metastases.
  • Inability to swallow oral medications.
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  • Other inclusion/exclusion criteria are specified in the protocol.

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