Moffitt Cancer Center: Clinical Trial 20579

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Clinical Trial 20579

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03175224

Phase: Phase I/II
Prinicipal Investigator: Benjamin Creelan

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study 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

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

Objective

Phase I Primary Objective To assess overall safety and tolerability, determine the dose limiting toxicities (DLTs), and identify the recommended Phase 2 dose (RP2D). Phase II Primary Objective: To assess efficacy by overall response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or relevant evaluation criteria per tumor type. Phase I/II Secondary Objectives: To assess incidence of serious adverse events (SAEs) and adverse events (AEs) by relationship and severity grade. To determine the pharmacokinetic (PK) parameters of orally administered APL-101. To assess efficacy by clinical benefit rate (CBR: CR + P R + S D ≥ 4 cycles), time to progression (TTP), progression free survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (or relevant evaluation criteria per tumor type) and overall survival (OS). Phase I/II Exploratory Objectives: To evaluate potential pharmacodynamic (PD) biomarkers of APL-101 and its correlation to the PK profile. To evaluate relationship of relevant biomarkers, including c-Met protein expression, amplification, and/or mutations to clinical response.

Treatments

Therapies

Medications

APL-101 ()

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

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.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.