Actively Recruiting
Phase 1 / 2 Multicenter Study of Safety, Pharmacokinetics, and Efficacy of APL-101 in Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and Advanced Solid Tumors
Led by Apollomics Inc. · Updated on 2025-06-27
497
Participants Needed
35
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and tolerability of APL-101 in treating various advanced solid tumors, especially non-small cell lung cancer (NSCLC) with MET Exon 14 skipping mutations, MET amplification, MET fusion, and tumors with overexpression of HGF and MET. This Phase 2 study follows a completed Phase 1 enrollment and focuses on patients with unresectable or metastatic cancers who have varying prior treatment histories and genetic tumor profiles. The study also examines APL-101 as an add-on therapy with EGFR inhibitors for NSCLC patients who developed resistance due to MET amplification. Participants receive APL-101 as oral capsules taken twice daily. The study includes multiple cohorts based on tumor type, prior treatment, and genetic characteristics, such as treatment-naive NSCLC patients with MET mutations, those previously treated with or without MET inhibitors, and patients with other solid tumors harboring specific MET alterations. One cohort also receives APL-101 combined with standard EGFR inhibitors. The treatment continues in cycles of 28 days, with ongoing assessment of response and safety. Throughout the study, participants undergo regular evaluations including imaging to identify measurable tumor lesions, laboratory tests, and functional assessments such as ECOG performance status or Karnofsky Performance Status for CNS tumors. Researchers measure outcomes like objective response rate, duration of response, time to progression, progression-free survival, and overall survival over periods extending up to three years. Safety monitoring includes organ function tests and tracking adverse effects. The total duration varies by participant based on treatment response and progression.
CONDITIONS
Brief 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
- Diagnosed with NSCLC or other solid tumors harboring MET alterations such as Exon 14 skipping mutations, MET amplification, MET fusion, or wild-type MET with HGF overexpression
- Unresectable or metastatic disease with no more than 3 prior lines of therapy in the metastatic setting
- No prior treatment with MET inhibitors and no known MET kinase inhibitor resistance mutations (except for specific cohorts)
- ECOG performance status of 0-1 or Karnofsky Performance Status of 70 or higher for CNS tumor patients
- Presence of at least one measurable lesion within 28 days before starting treatment
- Adequate organ and cardiac function
- Women of child-bearing potential must have a negative pregnancy test or evidence of sterility/post-menopausal status
- Expected survival of at least 3 months
- Ability to provide tumor tissue or liquid biopsy samples for study testing
- Asymptomatic or stable CNS disease allowed with controlled neurological symptoms and stable steroid use for at least 2 weeks prior to treatment start
You will not qualify if you...
- Allergy or hypersensitivity to APL-101 or its components
- Known actionable mutations in EGFR (except for certain cohorts), ALK, ROS1, RET, NTRK, KRAS, or BRAF
- Use or planned use of other investigational products during the study
- Active uncontrolled infections or serious disease that increases risk
- Life-threatening illness or significant organ dysfunction compromising safety or study integrity
- Unstable angina, recent heart attack within 1 year, unstable arrhythmia, prolonged QT interval, or use of medications prolonging QT
- Active hepatitis B or C with high viral load not controlled by therapy; unstable HIV infection
- Significant mental illness or substance abuse affecting compliance
- Unable to swallow oral medication whole
- Gastrointestinal disease affecting drug absorption
- Women who are breastfeeding
- History of other malignancies within 3 years unless considered cured or unlikely to recur
- Use of excluded medications that cannot be safely replaced prior to study drug
- Active COVID-19 infection
- Symptomatic or unstable CNS metastases requiring increased steroids to control disease progression within 2 weeks prior to treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive APL-101 oral capsules twice daily as treatment for their NSCLC or other solid tumors harboring MET alterations.
Visits occur regularly during treatment cycles
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
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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