APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumours

Official Title

Phase 1 / 2 Multicentre Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumours

Summary:

The primary Phase 1 purpose of this study is to assess overall safety and tolerability and recommended Phase 2 dose (RP2D) of APL-101. The Phase 2 portion will assess efficacy of the dose determined in Phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumours

Trial Description

Primary Outcome:

  • Estimate the maximum tolerated dose (MTD) and the incidence of DLTs
  • Determine response rate in Phase 2
Secondary Outcome:
  • Incidence of SAE and AEs
  • Area under the plasma concentration versus time curve (AUC)
  • Maximum plasma concentration
  • Time to reach Cmax
  • Duration of Response
  • Progression Free Survival
  • Overall Survival
This is a Phase 1/2, multi-centre, global, open-label, 2-part study with a Dose Escalation Segment and Dose and Disease Expansion Cohorts study of APL-101, a c-MET inhibitor, to determine the recommended Phase 2 dose (RP2D) and dose limiting toxicities for APL-101, and to obtain preliminary efficacy and target engagement data, in subjects with NSCLC and advanced malignancies with c-Met dysregulation. c-MET dysregulation will be determined from historical results by molecular pre-screening evaluations to determine eligibility of enrollment for both the Dose Escalation Segment (Phase 1) and Dose and Disease Expansion Cohorts (Phase 2). Dose escalation will occur until a protocol defined dose limited toxicity (DLT) occurs and a tentative maximum tolerated dose (MTD) is determined. Once dose is determined, five cohort groups will be further evaluated:
  • Cohort A-1: NSCLC EXON 14 skip mutation (c-Met naïve, 1L)
  • Cohort A-2: NSCLC EXON 14 skip mutation (c-Met naïve, 2/3L),
  • Cohort B: NSCLC EXON 14 skip mutation (c-Met experienced; progressed on prior c-Met inhibitor),
  • Cohort C: basket of tumour types (with c-Met high-level amplifications),
  • Cohort D: basket of tumour types (with c-Met fusions)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society