RecruitingPhase 2NCT03175224

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

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors


Sponsor

Apollomics Inc.

Enrollment

497 participants

Start Date

Sep 27, 2017

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called APL-101 for people with non-small cell lung cancer (NSCLC) that has a specific genetic mutation — called a MET Exon 14 skipping mutation — or in some cases, a very high number of copies of the MET gene, which drives cancer growth. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by tissue biopsy - Your tumor has a MET Exon 14 skipping mutation or very high MET gene amplification - You have advanced or metastatic disease (stage 3b or 4) - Depending on the study group, you may be eligible whether or not you have received prior MET-targeting treatments **You may NOT be eligible if...** - You have active brain metastases that are unstable - You have certain other cancers or serious organ problems - You are pregnant or breastfeeding - Your blood counts or organ function do not meet minimum thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPL-101 Oral Capsules

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


Locations(35)

Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

Moffitt

Tampa, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Wisconsin

Madison, Wisconsin, United States

St Vincents Hospital Melbourne

Melbourne, Australia

Cross Cancer Institute

Edmonton, Canada

McGill University Health Center - Research Institute

Montreal, Canada

Princess Margaret Hospital

Toronto, Canada

Cancer Care Manitoba

Winnipeg, Canada

CHRU de Brest - Hôpital Morvan

Brest, France

Centre Leon Berard

Lyon, France

Centre d'Essais Precoces en Cancerologie de Marseille

Marseille, France

Hopital Bichat - Claude Bernard - AP-HP

Paris, France

Gustave Roussy

Villejuif, France

Orszagos Koranyi Pulmonologiai Intezet

Budapest, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

Bologna, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera

Padova, Italy

Private Medical Institution Euromedservice

Saint Petersburg, Russia

National Cancer Centre Singapore

Singapore, Singapore

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

National Taiwan University Hospital

Taipei, Taiwan

University College London Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Royal Marsden Hospital - Surrey

Surrey Quays, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03175224


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