- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175224
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (SPARTA)
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
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Phase 1 (lead-in stage of this study) enrollment has been completed.
In this Phase 2 study, efficacy, safety, and tolerability will be assessed in the following cohorts:
- Cohort A-1: NSCLC EXON 14 skip mutation, previously untreated, MET inhibitor naive (c-Met naïve, 1L)
- Cohort A-2: NSCLC EXON 14 skip mutation, previously treated with ≤ 3 prior lines in unresectable or metastatic setting, MET inhibitor naive (c-Met naïve, 2/3L)
- Cohort B: NSCLC EXON 14 skip mutation, previously treated with ≤ 3 prior lines in unresectable or metastatic setting, MET inhibitor experienced (c-Met experienced; progressed on prior c-Met inhibitor)
- Cohort C: basket of tumor types (e.g., NSCLC, upper gastrointestinal [GI], colorectal, hepatobiliary cancer) harboring MET amplification except for primary CNS tumors, previously treated or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve
- Cohort C-1: NSCLC harboring MET amplification and wild-type epidermal growth factor receptor (EGFR), previously treated; or untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve
- Cohort C-2: EGFR positive NSCLC harboring MET amplification as an acquired resistance, documented response with first-line EGFR-Inhibitor (PR or CR per RECIST ≥ 12 weeks), radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy, MET inhibitor naïve
- Cohort D: basket of tumor types except for primary CNS tumors harboring MET gene fusions (e.g., NSCLC, upper GI, colorectal, hepatobiliary cancer), previously treated; or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve
- Cohort E: primary CNS tumors with MET alterations (single or co-occurred MET fusion including PTPRZ1-MET [ZM] fusion, MET Exon 14 skipping mutation, or MET amplification), previously treated or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines), MET inhibitor naïve
- Cohort F: basket of tumor types harboring wild-type MET with over-expression of HGF and MET (e.g., NSCLC, upper GI, colorectal, hepatobiliary cancer or primary CNS tumors), previously treated; or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Vivian Huey
- Phone Number: 6502094055
- Email: clinops@apollomicsinc.com
Study Locations
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Albury, Australia
- Recruiting
- Border Medical Oncology
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Frankston, Australia
- Recruiting
- Peninsula and Southeast Oncology
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Melbourne, Australia
- Recruiting
- St Vincents Hospital Melbourne
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Nedlands, Australia
- Recruiting
- Sir Charles Gairdner Hospital
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North Adelaide, Australia
- Active, not recruiting
- Calvary Central Districts Hospita
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South Australia
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Bedford Park, South Australia, Australia
- Recruiting
- Flinders Medical Centre
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Edmonton, Canada
- Recruiting
- Cross Cancer Institute
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Montréal, Canada
- Recruiting
- McGill University Health Center - Research Institute
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Toronto, Canada
- Recruiting
- Princess Margaret Hospital
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Winnipeg, Canada
- Recruiting
- Cancer Care Manitoba
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Quebec
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Montreal, Quebec, Canada
- Recruiting
- Lady Davis Institute for Medical Research Jewish General Hospital
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Tampere, Finland
- Recruiting
- Tampere University Hospital
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Brest, France
- Recruiting
- CHRU de Brest - Hôpital Morvan
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Lille, France
- Recruiting
- CHRU de Lille
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Lyon, France
- Recruiting
- Centre Leon Berard
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Marseille, France
- Recruiting
- Centre d'Essais Precoces en Cancerologie de Marseille
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Paris, France
- Recruiting
- Hopital Bichat - Claude Bernard - AP-HP
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Rennes, France
- Recruiting
- CHU Rennes - Hôpital Pontchaillou
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Villejuif, France
- Recruiting
- Gustave Roussy
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Budapest, Hungary
- Recruiting
- Orszagos Koranyi Pulmonologiai Intezet
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Tatabanya, Hungary
- Recruiting
- Szent Borbála Kórház
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Torokbalint, Hungary
- Recruiting
- Torokbalinti Tudogyogyintezet
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Ancona, Italy, 60126
- Recruiting
- Azienda Ospedaliero-Universitaria delle Marche
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Bologna, Italy
- Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
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Catania, Italy
- Recruiting
- Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
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Meldola, Italy
- Recruiting
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
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Milan, Italy
- Recruiting
- IRCCS Ospedale San Raffaele
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Milano, Italy
- Recruiting
- Istituto Europeo di Oncologia
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Principal Investigator:
- Fillipo De Marinis
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Padova, Italy
- Recruiting
- Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera
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Torino, Italy
- Recruiting
- AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
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Rio Piedras, Puerto Rico
- Recruiting
- PanOncology Trials, LLC
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Arkhangelsk, Russian Federation
- Active, not recruiting
- Arkhangelsk Clinical Oncological Dispensary
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Otradnoye, Russian Federation
- Active, not recruiting
- JSC Group of companies Medsi
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Saint Petersburg, Russian Federation
- Active, not recruiting
- Private Medical Institution Euromedservice
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Saint Petersburg, Russian Federation
- Active, not recruiting
- Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
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Saransk, Russian Federation
- Active, not recruiting
- Ogarev Mordovia State University
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St. Petersburg, Russian Federation
- Active, not recruiting
- JSC Current Medical Technologies
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Volgograd, Russian Federation
- Active, not recruiting
- Volgograd regional clinical oncology dispensary
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Singapore, Singapore
- Recruiting
- National Cancer Centre Singapore
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Singapore, Singapore
- Recruiting
- Oncocare Cancer Centre
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Singapore, Singapore
- Recruiting
- Tan Tock Seng Hospital
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Badalona, Spain
- Recruiting
- Hospital Germans Trias i Pujol
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Barcelona, Spain
- Recruiting
- Hospital del Mar
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Barcelona, Spain
- Recruiting
- Hospital Clinic Barcelona
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Barcelona, Spain
- Recruiting
- Institut Català d'Oncologia - L'Hospitalet
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Madrid, Spain
- Recruiting
- Hospital Universitario 12 de Octubre
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Madrid, Spain
- Recruiting
- Hospital General Universitario Gregorio Marañón
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Madrid, Spain
- Recruiting
- Hospital Universitario Ramon y Cajal
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Madrid, Spain
- Recruiting
- Hospital Universitario Puerta de Hierro Majadahonda
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Oviedo, Spain
- Recruiting
- Hospital Universitario Central de Asturias
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Sevilla, Spain
- Recruiting
- Hospital Universitario Virgen Del Rocio
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Valencia, Spain
- Recruiting
- Instituto Valenciano de Oncología
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Taichung, Taiwan
- Recruiting
- Taichung Veterans General Hospital
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Tainan, Taiwan
- Recruiting
- Chi-Mei Hospital - Liouying Branch
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Taipei City, Taiwan
- Recruiting
- National Taiwan University Hospital
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Taoyuan City, Taiwan
- Recruiting
- Linkou Chang Gung Memorial Hospital (CGMHLK)
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London, United Kingdom
- Recruiting
- University College London Hospital
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London, United Kingdom
- Active, not recruiting
- Imperial College Healthcare NHS Trust
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Manchester, United Kingdom
- Recruiting
- The Christie NHS foundation Trust
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Surrey Quays, United Kingdom
- Recruiting
- Royal Marsden Hospital - Surrey
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California
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Loma Linda, California, United States, 92354
- Active, not recruiting
- Loma Linda University Medical Center
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute
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Los Angeles, California, United States, 90033
- Active, not recruiting
- University of Southern California / Norris Comprehensive Cancer Center
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Riverside, California, United States, 92505
- Recruiting
- Kaiser Permanente - CA
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San Francisco, California, United States, 94158
- Not yet recruiting
- UCSF - Helen Diller Family Comprehensive Cancer Center
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Santa Monica, California, United States, 90404
- Recruiting
- Providence Medical Foundation
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Santa Rosa, California, United States, 95403
- Recruiting
- Providence St. Joseph Health
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Vallejo, California, United States, 94589
- Recruiting
- Kaiser Permanente - Vallejo
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Delaware
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Newark, Delaware, United States, 19713
- Recruiting
- Christiana Hospital
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Florida
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Fort Myers, Florida, United States, 33908
- Recruiting
- Florida Cancer Specialists - South
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Miami, Florida, United States, 33176
- Recruiting
- Miami Cancer Institute
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Saint Petersburg, Florida, United States, 33705
- Recruiting
- Florida Cancer Specialists - North
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Tallahassee, Florida, United States, 32308
- Recruiting
- Florida Cancer Specialists
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Tampa, Florida, United States, 33612
- Active, not recruiting
- Moffitt
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West Palm Beach, Florida, United States, 33401
- Recruiting
- Florida Cancer Specialists
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Maryland
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Silver Spring, Maryland, United States, 20904
- Recruiting
- Maryland Oncology Hematology
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Active, not recruiting
- Dana Farber Cancer Institute
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Minnesota
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Rochester, Minnesota, United States, 55905
- Active, not recruiting
- Mayo Clinic
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Saint Louis Park, Minnesota, United States, 55416
- Recruiting
- HealthPartners Cancer Research Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Recruiting
- University of North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
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Ohio
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Columbus, Ohio, United States, 43214
- Recruiting
- Ohio Health Research Institute
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Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University (OSU)
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Milton S. Hershey Medical Center
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South Carolina
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Greenville, South Carolina, United States, 29607
- Recruiting
- St. Francis Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon and HCA Research Institute
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Texas
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Amarillo, Texas, United States, 79106
- Recruiting
- The Don & Sybil Harrington Cancer Center
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West Virginia
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Morgantown, West Virginia, United States, 26506
- Recruiting
- West Virginia University Cancer Institute
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Contact:
- BSN
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Major Inclusion Criteria:
- Men and women 18 years of age or older.
9 cohorts will be enrolled:
- Cohort A1 / Exon 14 NSCLC MET inhibitor naive in first line: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease (Stage 3b/4); treatment-naive subjects in first line; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
- Cohort A2 / Exon 14 NSCLC - MET inhibitor naïve: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease (Stage 3b/4); pretreated subjects refractory to or intolerant of standard therapies with no more than three lines of prior therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
- Cohort B / Exon 14 NSCLC MET inhibitor experienced: ENROLLMENT COMPLETED
- Cohort C / MET amplification basket tumor types excluding primary CNS tumors: Any solid tumor type regardless of histology excluding primary CNS tumors, with MET amplification; unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
- Cohort C1 / MET amplification and wild-type EGFR NSCLC: NSCLC regardless of histology, harboring MET amplification and wild-type EGFR; unresectable or metastatic disease, previously untreated or treated with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
- Cohort C2 / EGFR positive NSCLC with acquired MET amplification (APL-101 Add-on Therapy): Unresectable or metastatic NSCLC regardless of histology, harboring EGFR activating mutations with acquired MET-Amplification as resistance mechanism to the EGFR-I; developed resistance to first-line EGFR-inhibitor therapy after an initial response (documented PR for at least 12 weeks); radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy; currently on an EGFR-inhibitor therapy and agrees to receive APL-101 as an add-on therapy during the study; no history of interstitial lung disease (ILD)/pneumonitis, Grade ≥3 liver toxicity or QT prolongation with EGFR-I therapy; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
- Cohort D / MET fusion basket tumor types excluding primary CNS tumors: any solid tumor type regardless of histology excluding primary CNS tumors; unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
- Cohort E / Primary CNS tumors with MET alterations: subjects with primary CNS tumors who meet inclusion criteria of MET dysregulations defined as single or co-occurred MET fusion including PTPRZ1-MET (ZM) fusion, MET Exon 14 skipping mutations, or MET amplification; refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations; neurological symptoms controlled on a stable/decreasing dose of steroids for at least 2 weeks before C1D1
- Cohort F / Basket tumor types harboring wild-type MET with over-expression of HGF and MET: any solid tumor type regardless of histology harboring wild-type MET with overexpression of HGF and MET; Unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
- Treated or untreated asymptomatic parenchymal CNS disease or leptomeningeal disease is allowed.
- Presence of ≥1 measurable lesion (scan done ≤28 days of C1D1) to serve as target lesion according to relevant criteria
- ECOG performance status of 0-1. For subjects with primary CNS tumors, KPS score ≥70.
- Acceptable organ function
- For all prior anticancer treatment, a duration of 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. Palliative radiotherapy to non-target lesions should be completed within 2 weeks prior to APL-101 administration.
- Adequate cardiac function
- Women of child-bearing potential must have a negative serum or Beta-hCG at screening or evidence of surgical sterility or evidence of post-menopausal status
- No planned major surgery within 4 weeks of first dose of APL-101
- Expected survival (life expectancy) ≥ 3 months from C1D1
- Provision of sample; e.g. archival or a fresh tumor biopsy sample (if safe and feasible) either from the primary or a metastatic site) or liquid biopsy sample (if tumor tissue is insufficient or lacking, and approved by the sponsor) is required for prospective central lab confirmation for study entry (subjects with previously confirmed molecular status by the Sponsor designated central lab or FDA approved NGS based MET testing may be exempted, subjected to Sponsor approval.
Major Exclusion Criteria:
- Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
- Known actionable mutation/gene rearrangement of EGFR (except for NSCLC subjects in Cohort C and C-2), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
- Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination.
- Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process, which in the opinion of the investigator makes the risk: benefit unfavorable for the participation of the trial.
- Life-threatening illness, significant organ system dysfunction or comorbid conditions, or other reasons that, in the investigator's opinion, could compromise the subject's safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of APL-101.
- 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, or concurrent treatment with a medication that is a known risk for prolonging the QT interval. Chronic controlled atrial fibrillation is not excluded.
- Historical seropositive results consistent with active infection for hepatitis C virus (HCV) or hepatitis B virus (HBV) with high viral loads not actively managed with antiviral therapy and human immunodeficiency virus (HIV) positive subjects who are not clinically stable or controlled on their medication (asymptomatic subjects with CD4+ T-cell (CD4+) counts ≥ 350 cells/μL and have not had an opportunistic infection within the past 12 months prior to first dose of APL-101 would be eligible for study entry. If history is unclear, relevant test(s) at Screening will be required to confirm eligibility.
- Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.
- Unable to swallow orally administered medication whole.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption
- Women who are breastfeeding
History of another malignancy within 3 years prior to C1D1. A subject with the following malignancies is allowed if considered cured or unlikely to recur within 3 years:
- Carcinoma of the skin without melanomatous features.
- Curatively treated cervical carcinoma in situ.
- Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (T1s), thyroid papillary cancer with prior treatment, prostate cancer which has been surgically or medically treated and not likely to recur within 3 years.
- Subjects who are unable or unwilling to discontinue excluded medications (drugs with known QTc risk and known strong cytochrome P450 [CYP]3A4 inducer and/or strong inhibitors) for at least 5 half-lives prior to first dose of study drug. Subjects may qualify if such medication(s) can be safely replaced with alternate medications with less risk of drug-drug interaction.
- Subjects with active COVID-19 infection.
- Symptomatic and/or neurologically unstable CNS metastases, or who require an increase in steroid dose to control CNS disease. Subjects who have been receiving a stable steroid dose for at least 2 weeks prior to C1D1 may be allowed.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NSCLC Exon 14 Skip Treatment Naive
Cohort A-1: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: NSCLC Exon 14 Skip Previously Treated
Cohort A-2: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: NSCLC Exon 14 MET Inhibitor Experienced
Cohort B: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: Basket of tumor types MET amplification except for primary CNS tumors
Cohort C: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: NSCLC MET amplification and EGFR wild-type
Cohort C-1: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: EGFR positive NSCLC MET amplification as an acquired resistance
Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: Basket of solid tumor with MET gene fusions except for primary CNS tumors
Cohort D: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: Primary CNS tumors with MET alterations
Cohort E: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
Experimental: Basket of tumor types wild-type MET with over-expression of HGF and MET
Cohort F: APL-101 Oral Capsules
|
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)
Time Frame: From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression
|
Anti-tumor activity per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
|
From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR per investigator assessment based on RECIST v1.1.
Time Frame: Approximately 2 years
|
ORR per RECIST v1.1 or relevant evaluation criteria per tumor type.
|
Approximately 2 years
|
Median time to progression (TTP).
Time Frame: Approximately 2 years
|
TTP per RECIST v1.1 or relevant evaluation criteria per tumor type.
|
Approximately 2 years
|
Progression Free Survival (PFS) and overall survival (OS) at 6, 12, 18 and 24 months
Time Frame: Approximately 3 years
|
PFS and OS per RECIST v1.1 or relevant evaluation criteria per tumor type.
|
Approximately 3 years
|
Median duration of response (DOR) per IRC.
Time Frame: Approximately 2 years
|
DOR per RECIST v1.1 criteria, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
|
Approximately 2 years
|
Median DOR per investigator assessment.
Time Frame: Approximately 2 years
|
DOR per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
|
Approximately 2 years
|
Antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1, RANO criteria for CNS tumors, or other relevant criteria per tumor type Median time to progression (TTP).
Time Frame: Approximately 2 years
|
Benefit rate per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
|
Approximately 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Marietta Franco, Apollomics Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Neoplasms
- Kidney Neoplasms
- Lung Neoplasms
- Glioblastoma
Other Study ID Numbers
- APL-101-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
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National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
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National Cancer Institute (NCI)CompletedGastric Cancer | Gastric NeoplasmsUnited States
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AIO-Studien-gGmbHBristol-Myers SquibbCompletedGastric Cancer | Esophageal Cancer | Adenocarcinoma Gastric | Metastatic Gastric Cancer | GastroEsophageal Cancer | HER2 Positive Gastric CancerGermany
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditionsUnited States
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Assistance Publique - Hôpitaux de ParisActive, not recruitingHereditary Diffuse Gastric CancerFrance
Clinical Trials on APL-101 Oral Capsules
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Apollomics Inc.Zhejiang CrownMab Biotech Co. LtdRecruiting
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Apollomics Inc.Recruiting
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Purdue Pharma, CanadaCompleted
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Purdue Pharma, CanadaCompleted
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University of CalgaryCumming school of medicine; The W. Garfield Westin FoundationRecruitingDepression | Treatment Resistant DepressionCanada
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Apollomics (Australia) Pty. Ltd.Novotech (Australia) Pty Limited; Apollomics Inc. (formerly CBT Pharmaceuticals...TerminatedRenal Cell Carcinoma | Hepatocellular CarcinomaAustralia, New Zealand
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Applied Molecular TransportActive, not recruitingUlcerative ColitisUnited States, Hungary, Ukraine, Germany, United Kingdom, Belarus, Bulgaria, Canada, France, Georgia, Moldova, Republic of, Poland, Russian Federation, Switzerland
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Montefiore Medical CenterCompletedIrritable Bowel SyndromeUnited States
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SunWay Biotech Co., LTD.RecruitingOverweight | Body Weight | Body FatTaiwan
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Medicines for Malaria VentureWashington University School of Medicine; Sanaria Inc.; Institute of Tropical... and other collaboratorsCompleted