Spots Global Cancer Trial Database for A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer
Official Title: A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy
Study ID: NCT04036682
Interventions
Study Description
Brief Summary: CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.
Detailed Description: This is a Phase 1/2, open-label, multicenter, first-in-human trial to evaluate the safety and tolerability, PK, PD, and efficacy of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. This trial is divided into multiple parts: Phase 1 Dose Escalation, Phase 2a Dose Expansion, Module A, Module B, and Module C. The objectives of the dose escalation and dose expansion parts are to determine the safety, tolerability, recommended Phase 2 dose (RP2D), and preliminary anti-tumor activity of orally administered CLN-081 monotherapy. The objective of Module A is to preliminarily assess the effect of food on the PK profile of CLN-081. The objective of Module B is to further characterize the safety and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior systemic anti-cancer treatment for locally advanced or metastatic disease. The objective of Module C is to explore the safety, tolerability, and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior treatment with an agent approved for EGFR exon 20 insertion mutant NSCLC CLN-081 will be dosed twice daily (BID).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pacific Cancer Medical Center, Inc, Anaheim, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
City of Hope at Irvine Lennar, Irvine, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
AdventHealth, Orlando, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan Health System - University Hospital, Ann Arbor, Michigan, United States
Summit Medical Group PA, Florham Park, New Jersey, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola, New York, United States
New York University Langone Health, New York, New York, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Providence Cancer Center, Portland, Oregon, United States
Providence Oncology & Hematology Care Clinic-Westside, Portland, Oregon, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Hong Kong University - Queen Mary Hospital, Hong Kong, , Hong Kong
Azienda Ospedaliero Universitaria Careggi, Careggi, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, Marche, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, , Italy
IRCCS-Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliero Universitaria Modena, Modena, , Italy
San Gerardo Hospital, Monza, , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
National Cancer Center Hospital East, Chiba, , Japan
Niigata Cancer Center, Niigata, , Japan
Osaka City General Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, , Japan
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital (SNUBH), Gyeonggi-do, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center (AMC), Soeul, , Korea, Republic of
Korea University Guro Hospital, Soeul, , Korea, Republic of
Ajou University Hospital, Suwon-si, , Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital, Suwon-si, , Korea, Republic of
The Netherlands Cancer Institute (NKI), Amsterdam, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Singapore Clinical Research Institute, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
University Hospital A Coruna, A Coruña, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Parc Tauli, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Institut Catala d'Oncologia l'Hospitalet, Barcelona, , Spain
START Barcelona, Barcelona, , Spain
Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas, , Spain
Hospital General Universitario Gregorio Maranon (HGUGM), Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda, Madrid, , Spain
University Hospital Quironsalud Madrid, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur), Valencia, , Spain
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital, Chiayi City, , Taiwan
Chung Shan Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Contact Details
Name: Zosia Piotrowska, MD
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR
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