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Trial record 2 of 2 for:    Recruiting Studies | Interventional Studies | Gastric Cancer | manitoba | Canada

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

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ClinicalTrials.gov Identifier: NCT03175224
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Apollomics Inc.

Brief Summary:

The primary Phase 1 purpose of this study is to assess overall safety and tolerability and recommended Phase 2 dose (RP2D) of APL-101.

The Phase 2 portion will assess efficacy of the dose determined in Phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors


Condition or disease Intervention/treatment Phase
Solid Tumor Advanced Cancer Renal Cancer Gastric Cancer Gastroesophageal Junction Adenocarcinoma NSCLC Lung Cancer Brain Tumor Glioblastoma Multiforme Drug: APL-101 Oral Capsules Phase 1 Phase 2

Detailed Description:

This is a Phase 1/2, multi-center, global, open-label, 2-part study with a Dose Escalation Segment and Dose and Disease Expansion Cohorts study of APL-101, a c-MET inhibitor, to determine the recommended Phase 2 dose (RP2D) and dose limiting toxicities for APL-101, and to obtain preliminary efficacy and target engagement data, in subjects with NSCLC and advanced malignancies with c-Met dysregulation.

c-MET dysregulation will be determined from historical results by molecular pre-screening evaluations to determine eligibility of enrollment for both the Dose Escalation Segment (Phase 1) and Dose and Disease Expansion Cohorts (Phase 2).

Dose escalation will occur until a protocol defined dose limited toxicity (DLT) occurs and a tentative maximum tolerated dose (MTD) is determined.

Once dose is determined, five cohort groups will be further evaluated:

  • Cohort A-1: NSCLC EXON 14 skip mutation (c-Met naïve, 1L)
  • Cohort A-2: NSCLC EXON 14 skip mutation (c-Met naïve, 2/3L),
  • Cohort B: NSCLC EXON 14 skip mutation (c-Met experienced; progressed on prior c-Met inhibitor),
  • Cohort C: basket of tumor types (with c-Met high-level amplifications),
  • Cohort D: basket of tumor types (with c-Met fusions)

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Study Type : Interventional
Estimated Enrollment : 201 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Phase 1: Subjects will be assigned to a dose level in the order of study entry. Treatment includes four planned dose levels (100 mg, 200 mg, 300 mg, and 400 mg).

Phase 2: Subjects will receive RP2D at 400mg daily dose (200mg BID).

Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2022


Arm Intervention/treatment
Experimental: Single-Arm
APL-101 Oral Capsules
Drug: APL-101 Oral Capsules

Phase 1 Subjects will be assigned to a dose level of APL-101 in the order of study entry. Treatment includes 28-day cycles at four planned dose levels (100mg, 200mg, 300mg and 400mg). Each treatment cycle is administered by daily oral capsules taken every 12 hours.

Phase 2 Subjects will be given 400mg daily dose (200mg BID) of APL-101 capsules.

Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib




Primary Outcome Measures :
  1. Estimate the maximum tolerated dose (MTD) and the incidence of DLTs [ Time Frame: From the time of informed consent signature through Cycle 1 (28 days) completion ]
    Adverse events, serious adverse events, and dose limiting toxicities

  2. Determine response rate in Phase 2 [ Time Frame: From time of informed consent signature through completion of Cycle 2 (1 cycle = 28 days) ]
    Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.


Secondary Outcome Measures :
  1. Incidence of SAE and AEs [ Time Frame: Approximately 1 year ]
    Adverse events, serious adverse events, and dose limiting toxicities according to the National Cancer Institute (NCI) Terminology Criteria for Adverse Events (CTCAE v4.03)

  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 2 months (1 cycle = 28 days) ]
    AUC, 0 - infinity

  3. Maximum plasma concentration [ Time Frame: Up to 2 months (1 cycle = 28 days) ]
    Cmax

  4. Time to reach Cmax [ Time Frame: Up to 2 months (1 cycle = 28 days) ]
    Tmax

  5. Duration of Response [ Time Frame: Approximately 24 months ]
    Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.

  6. Progression Free Survival [ Time Frame: Approximately 24 months ]
    Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.

  7. Overall Survival [ Time Frame: Approximately 24 months ]
    Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
  • For Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy.
  • For Phase 2, five cohorts will be enrolled: Cohort A-1: NSCLC EXON 14 skip mutation (c-Met naïve) for first line treatment, Cohort A-2: NSCLC EXON 14 skip mutation (c-Met naïve) pretreated subjects with no more than 3 lines of prior therapy, Cohort B: NSCLC EXON 14 skip mutation (c-Met experienced; radiographic progression on prior c-Met inhibitor), Cohort C: basket of tumor types with c-Met high level amplification (NSCLC EXON 14 skip mutation excluded), Cohort D: basket of tumor type with c-Met fusions.
  • Local/archival result (tissue and/or plasma) of a positive c-Met dysregulation is required
  • Measurable disease according to RECIST v1.1. (or relevant criteria per tumor type).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • For all prior anticancer treatment, including radiotherapy, chemotherapy or targeted agents or hormonal therapy, a duration of more than 30 days or 5 half-lives of the agents used, whichever is shorter, must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria prior to the first dose of study treatment.
  • No planned major surgery within 4 weeks of first dose of APL-101

Major Exclusion Criteria:

  • Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
  • Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
  • Unstable angina or myocardial infarction within 1 year prior to first dose of APL-101, symptomatic or unstable arrhythmia requiring medical therapy, history of congenital prolonged QT syndrome, prolonged QT interval corrected by Fridericia formula (QTcF) at screening (> 450 msec based on the average of 3 measurements), or concurrent treatment with a medication that is a known risk for prolonging the QT interval.
  • Unable to swallow orally administered medication whole.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
  • Women who are breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175224


Contacts
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Contact: Lynn Manlapaz-Espiritu 16502094055 infomed@apollomicsinc.com
Contact: Scott Houston 16502094055 infomed@apollomicsinc.com

Locations
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United States, Arizona
Banner MD Anderson Recruiting
Gilbert, Arizona, United States, 85234
Contact: Eileen Mozlen    480-256-5481    eileen.molzen@bannerhealth.com   
Principal Investigator: Jiaxin Niu, MD         
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Pamela McClure Study Coordinator    480-342-6076    Mcclure.pamela@mayo.edu   
Principal Investigator: Mahesh K Seetharam, MD         
United States, California
Kaiser Permanente - CA Recruiting
Escondido, California, United States, 92025
Contact: Lorena Bacon       Lorena.X.Bacon@kp.org   
Principal Investigator: Han Koh         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Tiffany Sanchez       tisanchez@llu.edu   
Principal Investigator: Hamid Mirshahidi         
University of Southern California / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Xiomara Menendez Study Coordinator    323-865-0212    xiomara.menendez@med.usc.edu   
Principal Investigator: Anthony El-Khoueiry, MD         
St. Joseph Health Recruiting
Santa Rosa, California, United States, 95403
Contact: Tracy Foster    707-521-3836    Tracy.Foster@stjoe.org   
Principal Investigator: Ian Anderson         
Kaiser Permanente - Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Desiree Goldstein       Desiree.Goldstein@kp.org   
Principal Investigator: Jennifer Suga, MD         
United States, Delaware
Christiana Care Recruiting
Newark, Delaware, United States, 19713
Contact: Denise DeMaio Study Coordinator       Denise.A.DeMaio@ChristianaCare.org   
Principal Investigator: Michael Guarino         
United States, Florida
Florida Cancer Specialists - South Recruiting
Fort Myers, Florida, United States, 33908
Contact: Patrice Cowan       pcowan@flcancer.com   
Principal Investigator: Anjan Patel, MD         
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Andrea Georgiou Study Coordinator    904-953-8667    georgiou.Andrea@mayo.edu   
Principal Investigator: Kabir Mody, MD         
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Stacy Fogg-Smith, MS    407-303-7325    Stacy.Fogg-Smith@AdventHealth.com   
Principal Investigator: Mark Socinski, MD         
Florida Cancer Specialists - North Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Dinah Welsh-Barnes       dibarnes@flcancer.com   
Principal Investigator: Vijay Patel, MD         
Florida Cancer Specialists Recruiting
Tallahassee, Florida, United States, 32308
Contact: Patricia Wright       pwright@flcancer.com   
Principal Investigator: Viralkumar Bhanderi, MD         
Moffitt Recruiting
Tampa, Florida, United States, 33612
Contact: Jeff Hunter       jeff.hunter@moffitt.org   
Principal Investigator: Ben Creelan         
Florida Cancer Specialists Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Jennifer Bar-nur       jbar-nur@flcancer.com   
Principal Investigator: Eric Harris, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Heather Scuderi       Heather.scuderi@ochsner.org   
Principal Investigator: Daniel Johnson         
United States, Maryland
Maryland Oncology Hematology Recruiting
Silver Spring, Maryland, United States, 20904
Contact: Zara Necesario       Zara.Necesario@usoncology.com   
Principal Investigator: Kashif Ali, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Phillip Yoon    617-975-7449    pyoon@bidmc.harvard.edu   
Principal Investigator: Daniel Costa         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michelle Xiong       michellex_xiong@dfci.harvard.edu   
Principal Investigator: Mark Awad, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ann Birgin Study Coordinator    507-266-7093    Birgin.ann@mayo.edu   
Principal Investigator: Sani H Kizilbash, MD, MPH         
Metro Minnesota Community Oncology Research Consortium Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Grant Gunderson Program Manager    952-993-1555    grant.gunderson@parknicollet.com   
Principal Investigator: Rachel Lerner         
United States, Missouri
HCA Midwest Health Recruiting
Kansas City, Missouri, United States, 66211
Contact: Stephanie May    816-276-4619    Stephanie.May@hcamidwest.com   
Principal Investigator: Syed Karim         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Cindy Fogal    314-362-1518    clfogal@wustl.edu   
Principal Investigator: Siddhartha Devarakonda, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Allie Mayer    919-966-4091    allie.mayer@med.unc.edu   
Principal Investigator: Claire Dees, MD         
United States, Ohio
The Ohio State University (OSU) Recruiting
Columbus, Ohio, United States, 43210
Contact: Morgan Hill       Morgan.Hill@osumc.edu   
Principal Investigator: Erin Bertino         
Kettering Health Network Recruiting
Kettering, Ohio, United States, 45429
Contact: Kelly Keeton Study Coordinator       kelly.keeton@ketteringhealth.org   
Principal Investigator: Emily Franks         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Wanda Neidig       wneidig@pennstatehealth.psu.edu   
Principal Investigator: Patrick Ma         
United States, South Carolina
St. Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Amy Adams Clinical Research Coordinator    864-603-6219    amy_adams@bshi.org   
Principal Investigator: Robert Siegel         
United States, Tennessee
Sarah Cannon and HCA Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Brittany Callaway    615-524-7283    brittany.callaway@sarahcannon.com   
Principal Investigator: David Spigel, MD         
United States, Texas
The Don & Sybil Harrington Cancer Center Recruiting
Amarillo, Texas, United States, 79106
Contact: Nancy Blades       Nancy.Blades@bsahs.org   
Principal Investigator: Anita Ravipati         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Arun Athithan       Arun.athithan@hci.utah.edu   
Principal Investigator: Sona Puri         
United States, Washington
MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: Stacey Macon Clinical Research Coordinator    253-403-0791    smmacon@multicare.org   
Principal Investigator: Jennifer Slim         
United States, West Virginia
West Virginia University Cancer Institute Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Sylvia McEwuen Study Coordinator, BSN    304-293-1683    smcewuen@hsc.wvu.edu   
Principal Investigator: Mohammed Almubarak, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Brittany Warnell Study Coordinator    608-265-0811    brittany.warnell@wisc.edu   
Principal Investigator: Mark Burkard         
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia
Contact: Alison Richards       alison.richards@sa.gov.au   
Principal Investigator: Chris Karapetis, MD         
Australia
Border Medical Oncology Recruiting
Albury, Australia
Contact: Cindy Shaw       cshaw@bordermedonc.com.au   
Principal Investigator: Criad Underhill         
St Vincents Hospital Melbourne Recruiting
Melbourne, Australia
Contact: Nadia Ranieri       Nadia.ranieri@svha.org.au   
Principal Investigator: Melissa Moore         
Sir Charles Gairdner Hospital Recruiting
Nedlands, Australia
Contact: Monica Lind       monica.lind@health.wa.gov.au   
Principal Investigator: Kevin Jasas, MD         
Calvary Central Districts Hospita Recruiting
North Adelaide, Australia
Contact: Sophie Smith       sophie.smith@calvarycare.org.au   
Principal Investigator: Vineet Kwatra, MD         
Canada, Quebec
Lady Davis Institute for Medical Research Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Daria Krutauz    514-340-8222 ext: 24301    daria.krutauz.ccomtl@ssss.gouv.qc.ca   
Principal Investigator: Jason Agulnik         
Canada
Cross Cancer Institute Recruiting
Edmonton, Canada
Contact: Dominique Forrest       Dominique.Forrest@albertahealthservices.ca   
Principal Investigator: Siu-Chung (Quincy) Chu         
McGill University Health Center - Research Institute Recruiting
Montréal, Canada
Contact: Nicola Raby       nicola.raby@muhc.mcgill.ca   
Principal Investigator: Scott Owen         
Princess Margaret Hospital Recruiting
Toronto, Canada
Contact: Maggie Sawczak       Maggie.Sawczak@uhn.ca   
Principal Investigator: Natasha Leighl         
Cancer Care Manitoba Recruiting
Winnipeg, Canada
Contact: Robyn Guarino       rguarino@cancercare.mb.ca   
Principal Investigator: Shantanu Banerji         
Finland
Helsinki University Central Hospita Recruiting
Helsinki, Finland
Contact: Kerstin Ahlskog       kerstin.ahlskog@hus.fi   
Principal Investigator: Aija Knuuttila         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Marjo Koivisto       marjo.koivisto@pshp.fi   
Principal Investigator: Jaarko Ahvonen         
France
CHRU de Brest - Hôpital Morvan Recruiting
Brest, France
Contact: Amellie Crie       amelie.crie@chu-brest.fr   
Principal Investigator: Gilles Robinet         
CHRU de Lille Recruiting
Lille, France
Contact: Eric Wasielewski       eric.wasielewski@chru-lille.fr   
Principal Investigator: Alexis Cortot         
Centre Leon Berard Recruiting
Lyon, France
Contact: Maryem Lahbib       Maryem.LAHBIB@lyon.unicancer.fr   
Principal Investigator: Maurice Perol         
Hopital Bichat - Claude Bernard - AP-HP Recruiting
Paris, France
Contact: Celine Namour       celine.namour@aphp.fr   
Principal Investigator: Gerard Zalcman         
CHU Rennes - Hopital Pontchaillou Recruiting
Rennes, France
Contact: Laurène Masson       Laurene.MASSON@chu-rennes.fr   
Principal Investigator: Herve Lena         
Gustave Roussy Recruiting
Villejuif, France
Contact: Hannane Hamidi       Hannane.HAMIDI@gustaveroussy.fr   
Principal Investigator: David Planchard         
Italy
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico Recruiting
Catania, Italy
Contact: Sonia Attina       attinasonia.sc@gmail.com   
Principal Investigator: Manuela Lo Porto Soto Parra         
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy
Contact: Flavia Pagan    +39 0543 739 423    flavia.pagan@irst.emr.it   
Principal Investigator: Angelo Delmonte         
IRCCS Ospedale San Raffaele Recruiting
Milan, Italy
Contact: Clara Fugazza       fugazza.clara@hsr.it   
Principal Investigator: Vanesa Gregorc         
Puerto Rico
PanOncology Trials, LLC Recruiting
Rio Piedras, Puerto Rico
Contact: Virginia Ramirez    787-607-3336    virginia.ramirez@panoncologytrials.com   
Principal Investigator: Marcia Cruz-Correa         
Russian Federation
Arkhangelsk Clinical Oncological Dispensary Recruiting
Arkhangelsk, Russian Federation
Contact: Sarina Anastasia       sharinaay@yandex.ru   
Principal Investigator: Marina Nechaeva         
Private Medical Institution Euromedservice Recruiting
Saint Petersburg, Russian Federation
Contact: Aleksandr Krestianinov       Krestalexserg@gmail.com   
Principal Investigator: Konstantin Penkov         
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology) Recruiting
Saint Petersburg, Russian Federation
Contact: Mariia Gutina       veselova.oncocentr@mail.ru   
Principal Investigator: Fedor Moiseenko         
Ogarev Mordovia State University Recruiting
Saransk, Russian Federation
Contact: Artem Ivashin       a.iwashin2017@yandex.ru   
Principal Investigator: Pavel Skopin         
JSC Current Medical Technologies Recruiting
St. Petersburg, Russian Federation
Contact: Svetlana Kryukova       tretnikovasvetlana@gmail.com   
Principal Investigator: Svetlana Odintsova         
Volgograd Regional Clinical Oncology Dispensary Recruiting
Volgograd, Russian Federation
Contact: Marakova Lyubov       makarova.lyubov.vlg@gmail.com   
Principal Investigator: Nadezhda Kovalenko         
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore
Contact: Shiling Chua    chua.shi.ling@nccs.com.sg    chua.shi.ling@nccs.com.sg   
Principal Investigator: Geet Yi Gillianne Lai         
Oncocare Cancer Centre Recruiting
Singapore, Singapore
Contact: Vera Chen       Vera_Chen@oncocare.sg ; veraqxchen@gmail.com   
Principal Investigator: Swan Swan Leong         
Tan Tock Seng Hospital Recruiting
Singapore, Singapore
Contact: Jamie Jia Min Ng       Jamie_JM_NG@ttsh.com.sg   
Principal Investigator: Puey ling Chia         
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Spain
Contact: Sandra Saldaña       ssaldana@igtp.cat   
Principal Investigator: Enric Carcereny Costa         
Hospital Clinic Barcelona Recruiting
Barcelona, Spain
Contact: Ainara Arcocha       AARCOCHA@clinic.cat   
Principal Investigator: Noemi Reguart         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Susana Galtes       sgaltescruces@parcdesalutmar.cat   
Principal Investigator: Alvaro Taus         
Oncologia Mèdica Recruiting
Barcelona, Spain
Contact: Begoña Hernández Coll       bhernandezc@idibell.cat   
Principal Investigator: Ernest Nadal         
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain
Contact: Cristina Villar Rodriguez       crisrvillar83.hgugm@gmail.com   
Principal Investigator: Antonio Calles Blanco         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Raquel Rodriguez       rrodriguez@h12o.es   
Principal Investigator: Santiago Ponce         
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Madrid, Spain
Contact: Sandra Cerdeira    +34 91 191 7418    scerdeira.hpth@salud.madrid.org   
Principal Investigator: Mariano Provencio         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain
Contact: Elena Ruiz       elena.ruizal@salud.madrid.org   
Principal Investigator: Pilar Garrido         
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Majadahonda, Spain
Contact: Sandra Cerdeira       scerdeira.hpth@salud.madrid.org   
Principal Investigator: Mariana Provencio         
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain
Contact: Esther Uriol Egido       uriol.esther@hotmail.com   
Principal Investigator: Emilio Esteban         
Hospital Universitario Donostia Recruiting
San Sebastián, Spain
Contact: Maria Diez       maria.diezzubizarreta@osakidetza.eus   
Principal Investigator: Alfredo Paredes Lario         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain
Contact: Esperanza Munoz       espe.m.garcia@gmail.com   
Principal Investigator: Reyes Bernabe         
Instituto Valenciano de Oncologia Recruiting
Valencia, Spain
Contact: Amparo Ortiz       datamanager6@fincivo.org   
Principal Investigator: Angel Guerrero Zotano         
Taiwan
Taipei Medical University - Shuang Ho Hospital Recruiting
New Taipei City, Taiwan
Contact: Yi-Ping Chi       20232@s.tmu.edu.tw   
Principal Investigator: Kang-Yun Lee         
Chi-Mei Hospital - Liouying Branch Recruiting
Tainan, Taiwan
Contact: Olivia Chen       hospital77649@gmail.com   
Principal Investigator: Chao-Jung Tsao         
National Taiwan University Hospital Recruiting
Taipei City, Taiwan
Contact: Wen Pei Lin       906329@ntuh.gov.tw   
Principal Investigator: James Chih-Hsin Yang         
Taipei Medical University Hospital Recruiting
Taipei, Taiwan
Contact: Hsiao-Ling Liu       acis70@gmail.com   
Principal Investigator: Han-Pin Kuo         
Linkou Chang Gung Memorial Hospital (CGMHLK) Recruiting
Taoyuan City, Taiwan
Contact: Yi-Shiou Hsiao       ifyn1011@hotmail.com   
Principal Investigator: Cheng-Ta Yang         
Ukraine
City Hematology Center of Municipal Non-Profit Enterprise "City Clinical Hospital #4" DCC Recruiting
Dnipropetrovs'k, Ukraine
Principal Investigator: Igor Bondarenko         
Kharkivskyi Oblasnyi Klinichnyi Onkologichnyi Tsentr Recruiting
Kharkiv, Ukraine
Contact: Kateryna Kotelevets       kotelevets15@gmail.com   
Principal Investigator: Dmytro Shapovalov, MD         
Kharkov Medical Academy of Postgraduate Education Recruiting
Kharkiv, Ukraine
Principal Investigator: Oleksandr Dudnichenko, MD         
Kyiv Municipal Clinical Oncology Center Recruiting
Kyiv, Ukraine
Principal Investigator: Olga Ponomarova, MD         
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Maria Martinez       m.martinez@nhs.net   
Principal Investigator: David Pinato         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Sharon Wooley       sharon.woolley@christie.nhs.uk   
Principal Investigator: Colin Lindsay         
Royal Marsden Hospital - Surrey Recruiting
Surrey Quays, United Kingdom
Principal Investigator: Anna Minchom, MD         
Sponsors and Collaborators
Apollomics Inc.
Investigators
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Study Director: Lynn Manlapaz-Espiritu Sr Director, Clinical Operations
Additional Information:
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Responsible Party: Apollomics Inc.
ClinicalTrials.gov Identifier: NCT03175224    
Other Study ID Numbers: APL-101-01
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Apollomics Inc.:
Advanced Solid Tumor
Relapsed Solid Tumor
Recurrent Solid Tumor
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Kidney Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Urologic Neoplasms
Urogenital Neoplasms
Glioblastoma
Lung Diseases
Respiratory Tract Diseases
Astrocytoma
Glioma
Kidney Diseases
Urologic Diseases