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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

Trial Status: Active

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

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

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.

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Xiomara Menendez
Phone: 323-865-0212
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Stacey Green
Phone: 310-825-5321
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Jubilee Grace P. Acap
Phone: 323-865-0593
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Cristina de Leon
Phone: 949-764-5543
San Francisco
UCSF Medical Center-Mount Zion
Status: ADMINISTRATIVELY_COMPLETE
Contact: McNancy Kang
Phone: 415-476-9608

Florida

Jacksonville
Mayo Clinic in Florida
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Tampa
Moffitt Cancer Center
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

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)

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Apollomics Inc.

  • Primary ID APL-101-01 (CBT-101-01)
  • Secondary IDs NCI-2017-01648, CBT-101-01
  • Clinicaltrials.gov ID NCT03175224