APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
a study on Solid Tumor Cancer, General Kidney Cancer Stomach Cancer Gastroesophageal Junction Adenocarcinoma Gastroesophageal Junction Cancer Non-Small Cell Lung Cancer Lung Cancer Brain Tumor Astrocytoma Glioblastoma Glioma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Vallejo, California and other locations
- Dates
- study startedestimated completion
- Principal Investigator
- by Pamela Munster
Description
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
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
Details
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)
Keywords
Solid Tumor Advanced Cancer Renal Cancer Gastric Cancer Gastroesophageal Junction Adenocarcinoma NSCLC Lung Cancer Brain Tumor Glioblastoma Multiforme Advanced Solid Tumor Relapsed Solid Tumor Recurrent Solid Tumor Neoplasms Lung Neoplasms Glioblastoma Kidney Neoplasms APL-101 Oral Capsules
Eligibility
For people ages 18 years and up
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 targeted/hormonal 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, or symptomatic or unstable arrhythmia requiring medical therapy, or history of congenital prolonged QT syndrome or whose corrected QT interval by Fridericia formula (QTcF) at screening is prolonged (> 450 msec based on the average of 3 measurements) 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.
Locations
- Kaiser Permanente - Vallejo
accepting new patients
Vallejo California 94589 United States - St. Joseph Health
accepting new patients
Santa Rosa California 95403 United States
Lead Scientist at UCSF
- Pamela Munster
Professor, Medicine. Authored (or co-authored) 129 research publications.
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Apollomics Inc.
- Links
- Apollomics, Inc. website SPARTA Study website
- ID
- NCT03175224
- Phase
- Phase 1/2
- Study Type
- Interventional
- Last Updated
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