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 |
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Recruitment Status :
Recruiting
First Posted : June 5, 2017
Last Update Posted : December 20, 2019
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Sponsor:
Apollomics Inc.
Information provided by (Responsible Party):
Apollomics Inc.
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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 | Drug: APL-101 Oral Capsules | Phase 1 Phase 2 |
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, four cohort groups will be further evaluated: Cohort A: EXON 14 NSCLC (c-Met naïve), Cohort B: EXON 14 NSCLC (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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 145 participants |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Subjects will be assigned to a dose level in the order of study entry. Treatment includes five planned dose levels (100 mg, 200 mg, 300 mg, 400 mg, 500 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
Genetics Home Reference related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Single-Arm
APL-101 Oral Capsules
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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 five planned dose levels (100 mg, 200 mg, 300 mg, 400 mg, 500 mg). Each treatment cycle is administered by daily oral capsules taken every 12 hours.
Other Names:
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Primary Outcome Measures :
- 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
- 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 :
- 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)
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 2 months (1 cycle = 28 days) ]AUC, 0 - infinity
- Maximum plasma concentration [ Time Frame: Up to 2 months (1 cycle = 28 days) ]Cmax
- Time to reach Cmax [ Time Frame: Up to 2 months (1 cycle = 28 days) ]Tmax
- Duration of Response [ Time Frame: Approximately 24 months ]Anti-tumor activity per RECIST v1.1
- Progression Free Survival [ Time Frame: Approximately 24 months ]Anti-tumor activity per RECIST v1.1
- Overall Survival [ Time Frame: Approximately 24 months ]Anti-tumor activity per RECIST v1.1
Information from the National Library of Medicine
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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 locally advanced, recurrent or relapsed or metastatic incurable solid malignancy
- For Phase 2, four cohorts will be enrolled: Cohort A: EXON 14 NSCLC (c-Met naïve), Cohort B: EXON 14 NSCLC (c-Met experienced; progressed on prior c-Met inhibitor), Cohort C: basket of tumor types with c-Met high amplification, Cohort D: basket of tumor types 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 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, ALK, ROS1, RET, NTRK, KRAS, BRAF or other driver mutation/gene rearrangement apart from MET
- History of, 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.
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
| Contact: Lynn Manlapaz-Espiritu | 650-209-4055 | Lenilyn.Espiritu@apollomicsinc.com | |
| Contact: Gavin Choy, PharmD, MBA | 650-209-4055 | gavin.choy@apollomicsinc.com |
Locations
| 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, 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
| Study Director: | Lynn Manlapaz-Espiritu | Senior Director, Clinical Operations |
Additional Information:
| 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: | December 20, 2019 |
| Last Verified: | December 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Apollomics Inc.:
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Advanced Solid Tumor Relapsed Solid Tumor Recurrent Solid Tumor |
Additional relevant MeSH terms:
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Lung Neoplasms Adenocarcinoma 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 Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases |