Actively Recruiting
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Led by Apollomics Inc. · Updated on 2025-06-27
497
Participants Needed
35
Research Sites
478 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older.
- Enrollment in one of nine specific cohorts defined by tumor type, mutation status, prior treatments, and MET inhibitor exposure.
- Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations or solid tumors with MET alterations.
- Unresectable or metastatic disease (Stage 3b/4) for NSCLC cohorts.
- Treatment-naive or previously treated with no more than three prior therapy lines in unresectable or metastatic setting.
- Presence of at least one measurable lesion within 28 days before treatment start.
- ECOG performance status of 0-1; for primary CNS tumors, Karnofsky Performance Status score of 70 or higher.
- Adequate organ and cardiac function.
- Prior anticancer treatments completed at least 30 days or 5 half-lives before study treatment, with resolved toxicities.
- Women of child-bearing potential must have a negative pregnancy test or evidence of sterility/post-menopause.
- No planned major surgery within 4 weeks of first dose.
- Expected survival of at least 3 months.
- Provision of tumor or liquid biopsy sample for molecular testing.
- Neurologic symptoms controlled with stable or decreasing steroid dose for at least 2 weeks before treatment (for CNS tumor cohort).
- Treated or untreated asymptomatic brain or leptomeningeal disease allowed.
You will not qualify if you...
- Allergy or hypersensitivity to APL-101 or its components.
- Known actionable mutations or gene rearrangements in EGFR (except specified cohorts), ALK, ROS1, RET, NTRK, KRAS, or BRAF.
- Use or planned use of other investigational products during the study.
- Active uncontrolled infections or significant active diseases posing risk.
- Life-threatening illness, significant organ dysfunction, or comorbidities compromising safety or study integrity.
- Recent unstable angina, myocardial infarction, symptomatic arrhythmia, or prolonged QT interval.
- Active hepatitis B or C with high viral load not managed, or unstable HIV infection.
- Significant mental illness or substance abuse risking noncompliance.
- Inability to swallow oral medication whole.
- Gastrointestinal conditions affecting drug absorption.
- Women who are breastfeeding.
- History of other malignancies within 3 years, except certain cured or low-risk cancers.
- Inability or unwillingness to stop excluded medications affecting QTc or CYP3A4 interactions.
- Active COVID-19 infection.
- Symptomatic or unstable CNS metastases requiring steroid dose increase.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Actively Recruiting
2
Moffitt
Tampa, Florida, United States, 33612
Active, Not Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
5
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
6
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
7
St Vincents Hospital Melbourne
Melbourne, Australia
Actively Recruiting
8
Cross Cancer Institute
Edmonton, Canada
Actively Recruiting
9
McGill University Health Center - Research Institute
Montreal, Canada
Actively Recruiting
10
Princess Margaret Hospital
Toronto, Canada
Actively Recruiting
11
Cancer Care Manitoba
Winnipeg, Canada
Actively Recruiting
12
CHRU de Brest - Hôpital Morvan
Brest, France
Actively Recruiting
13
Centre Leon Berard
Lyon, France
Actively Recruiting
14
Centre d'Essais Precoces en Cancerologie de Marseille
Marseille, France
Actively Recruiting
15
Hopital Bichat - Claude Bernard - AP-HP
Paris, France
Actively Recruiting
16
Gustave Roussy
Villejuif, France
Actively Recruiting
17
Orszagos Koranyi Pulmonologiai Intezet
Budapest, Hungary
Actively Recruiting
18
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Hungary
Actively Recruiting
19
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy
Actively Recruiting
20
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Actively Recruiting
21
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
22
Istituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
23
Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera
Padova, Italy
Actively Recruiting
24
Private Medical Institution Euromedservice
Saint Petersburg, Russia
Active, Not Recruiting
25
National Cancer Centre Singapore
Singapore, Singapore
Actively Recruiting
26
Hospital Germans Trias i Pujol
Badalona, Spain
Actively Recruiting
27
Hospital Clinic Barcelona
Barcelona, Spain
Actively Recruiting
28
Hospital del Mar
Barcelona, Spain
Actively Recruiting
29
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, Spain
Actively Recruiting
30
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
31
Instituto Valenciano de Oncologia
Valencia, Spain
Actively Recruiting
32
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
33
University College London Hospital
London, United Kingdom
Actively Recruiting
34
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
35
Royal Marsden Hospital - Surrey
Surrey Quays, United Kingdom
Actively Recruiting
Research Team
E
Emma (Xiaoning) Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
9
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