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

NCT03175224 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 497

Last updated 2025-06-27

No results posted yet for this study

Summary

To assess:

* efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET
* efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)

Conditions

Interventions

DRUG

APL-101 Oral Capsules

Subjects will receive APL-101 capsules BID for oral administration.

Sponsors & Collaborators

  • Apollomics Inc.

    lead INDUSTRY

Principal Investigators

  • Mythili Sangem · Apollomics Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-27
Primary Completion
2026-03-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Hungary
  • Italy
  • Russia
  • Singapore
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03175224 on ClinicalTrials.gov