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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03175224
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Apollomics Inc.

Study Description
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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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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).
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, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single-Arm
APL-101 Oral Capsules
 Drug: APL-101 Oral Capsules
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 (100 mg, 200 mg, 300 mg and 400 mg). Each treatment cycle is administered by daily oral capsules taken every 12 hours.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101


Outcome Measures
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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


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

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

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


Eligibility Criteria
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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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • No chemotherapy treatments within at least 3 weeks prior to 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.
  • History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs 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.
Contacts and Locations
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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 650-209-4055 Lenilyn.Espiritu@apollomicsinc.com
Contact: Gavin Choy, PharmD, MBA 650-209-4055 gavin.choy@apollomicsinc.com

Locations
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United States, Arizona
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
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         
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
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         
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, 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
Kettering Health Network Recruiting
Kettering, Ohio, United States, 45429
Contact: Kelly Keeton Study Coordinator       kelly.keeton@ketteringhealth.org   
Principal Investigator: Emily Franks         
United States, South Carolina
Bon Secours 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, 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         
Sponsors and Collaborators
Apollomics Inc.
Investigators
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Study Director: Lynn Manlapaz-Espiritu Senior Director, Clinical Operations
More Information
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Additional Information:

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Responsible Party: Apollomics Inc.
ClinicalTrials.gov Identifier: NCT03175224    
Other Study ID Numbers: APL-101-01 (CBT-101-01)
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
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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Lung Neoplasms
Adenocarcinoma
Glioblastoma
Kidney Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases