Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion

Description

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 Tumors

Official Title

Phase 1 / 2 Multicenter 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 Tumors

Details

This is a Phase 1/2, multi-center, 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, four cohort groups will be further evaluated: Cohort A: EXON 14 NSCLC (c-Met naïve), Cohort B: EXON 14 NSCLC (c-Met experienced; progressed on prior c-Met inhibitor), Cohort C: basket of tumor types (with c-Met high-level amplifications), Cohort D: basket of tumor types (with c-Met fusions)

Keywords

Solid Tumor Advanced Cancer Renal Cancer Gastric Cancer Gastroesophageal Junction Adenocarcinoma NSCLC Lung Cancer Advanced Solid Tumor Relapsed Solid Tumor Recurrent Solid Tumor Lung Neoplasms Adenocarcinoma Kidney Neoplasms Neoplasms APL-101 Oral Capsules

Eligibility

For people ages 18 years and up

Major Inclusion Criteria:

  • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
  • For Phase 1, histologically and / or cytological confirmed locally advanced, recurrent or relapsed or metastatic incurable solid malignancy
  • For Phase 2, four cohorts will be enrolled: Cohort A: EXON 14 NSCLC (c-Met naïve),

Cohort B: EXON 14 NSCLC (c-Met experienced; progressed on prior c-Met inhibitor),

Cohort C: basket of tumor types with c-Met high amplification, Cohort D: basket of tumor types with c-Met fusions.

  • Local/archival result (tissue and/or plasma) of a positive c-Met dysregulation is required
  • Measurable disease according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • No planned major surgery within 4 weeks of first dose of APL-101

Major Exclusion Criteria:

  • Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
  • Known mutation/gene rearrangement of EGFR, ALK, ROS1, RET, NTRK, KRAS, BRAF or other driver mutation/gene rearrangement apart from MET
  • History of, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
  • Unable to swallow orally administered medication whole.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
  • Women who are breastfeeding.

Locations

  • University of Southern California / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • Mayo Clinic accepting new patients
    Phoenix Arizona 85054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Apollomics Inc.
Links
Company website for Apollomics, Inc.
ID
NCT03175224
Phase
Phase 1/2
Study Type
Interventional
Last Updated