Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion
Pamela Munster, MD(ucsf)

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 Advance 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 Advance Solid Tumors

Details

This is a Phase 1, multi-center, 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 and Dose and Disease Expansion Cohorts. However, in the Dose and Disease Expansion Cohorts, the c-MET historical results will be confirmed by a central laboratory retrospectively, but will not be a determinant for study entry.

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, three 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 dysregulation (amplification or mutation or 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 (formerly CBT-101)

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, three 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 dysregulation (amplification or mutation or fusions).

  • Measurable disease according to RECIST v1.1. 7.
  • 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 CBT-101, excipients of the drug product, or other components of the study treatment regimen.
  • Known mutation of EGFR, ALK or ROS1 or have received a kinase inhibitor for these mutations
  • History of, or at risk for, cardiac disease (e.g., long QTc syndrome [> 450 msec] or concurrent treatment with any medication that prolongs QT interval).
  • Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptic and requiring high doses of steroids.
  • 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

  • Univeristy of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • University of Southern California / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist

  • Pamela Munster, MD (ucsf)
    Professor, Medicine. Authored (or co-authored) 116 research publications

Details

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