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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Apollomics Inc.
Study ID
NCT03175224
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APL-101 Oral Capsules — DRUG
    Subjects will receive APL-101 capsules BID for oral administration.

Study Details

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)

Key Dates

Start date
Sep 27, 2017
Status verified
Jun 2025
Primary completion
Mar 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
497 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NSCLC Exon 14 Skip Treatment Naive
    Cohort A-1: APL-101 Oral Capsules
  • Experimental: NSCLC Exon 14 Skip Previously Treated
    Cohort A-2: APL-101 Oral Capsules
  • Experimental: NSCLC Exon 14 MET Inhibitor Experienced
    Cohort B: APL-101 Oral Capsules
  • Experimental: Basket of tumor types MET amplification except for primary CNS tumors
    Cohort C: APL-101 Oral Capsules
  • Experimental: NSCLC MET amplification and EGFR wild-type
    Cohort C-1: APL-101 Oral Capsules
  • Experimental: EGFR positive NSCLC MET amplification as an acquired resistance
    Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor
  • Experimental: Basket of solid tumor with MET gene fusions except for primary CNS tumors
    Cohort D: APL-101 Oral Capsules
  • Experimental: Primary CNS tumors with MET alterations
    Cohort E: APL-101 Oral Capsules
  • Experimental: Basket of tumor types wild-type MET with over-expression of HGF and MET
    Cohort F: APL-101 Oral Capsules

Primary Outcome Measure

Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type) [ Time Frame: From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
MoffittTampaFlorida33612-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of North CarolinaChapel HillNorth Carolina27599-
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-
University of WisconsinMadisonWisconsin53792-

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OncologyNeuro-oncologyGI oncologyLung oncologyLung diseaseUrology
By research site
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CAMoffitt· Tampa, FLDana Farber Cancer Institute· Boston, MAUniversity of North Carolina· Chapel Hill, NCPenn State Milton S. Hershey Medical Center· Hershey, PAUniversity of Wisconsin· Madison, WI

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