OncoMatch/Clinical Trials/NCT03175224
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Is NCT03175224 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies APL-101 Oral Capsules for solid tumors.
Treatment: APL-101 Oral Capsules — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Renal Cell Carcinoma
Gastric Cancer
Esophageal Carcinoma
Non-Small Cell Lung Carcinoma
Glioblastoma
Thyroid Cancer
Pancreatic Cancer
Colorectal Cancer
Biomarker criteria
Required: MET exon 14 skipping mutation
NSCLC with Exon 14 skipping mutations
Required: MET amplification
with MET amplification
Required: EGFR activating mutation
EGFR activating mutations with acquired MET-Amplification as resistance mechanism to the EGFR-I
Required: MET fusion
MET fusion including PTPRZ1-MET (ZM) fusion
Required: MET wild-type
wild-type MET with overexpression of HGF and MET
Required: HGF overexpression
overexpression of HGF
Required: MET overexpression
overexpression of ... MET
Required: EGFR wild-type
harboring MET amplification and wild-type EGFR
Required: EGFR wild-type
wild-type MET with overexpression of HGF and MET
Excluded: EGFR actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of EGFR (except for NSCLC subjects in Cohort C and C-2)
Excluded: ALK actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... ALK
Excluded: ROS1 actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... ROS1
Excluded: RET actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... RET
Excluded: NTRK1 actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... NTRK
Excluded: NTRK2 actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... NTRK
Excluded: NTRK3 actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... NTRK
Excluded: KRAS actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... KRAS
Excluded: BRAF actionable mutation/gene rearrangement
Known actionable mutation/gene rearrangement of ... BRAF
Disease stage
Required: Stage 3B, IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: met inhibitor
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Adequate cardiac function
Acceptable organ function; Adequate cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute · Los Angeles, California
- Moffitt · Tampa, Florida
- Dana Farber Cancer Institute · Boston, Massachusetts
- University of North Carolina · Chapel Hill, North Carolina
- Penn State Milton S. Hershey Medical Center · Hershey, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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