APL-101 Study Of Subjects With NSCLC With C-Met EXON 14 Skip Mutations And C-Met Dysregulation Advanced Solid Tumors (SPARTA)

Overview

About this study

This is a Phase 1 / 2 open-label study to assess the safety and tolerability of APL-101, to determine the RP2D and dose limiting toxicities for APL-101, and to obtain preliminary efficacy in subjects
with c-Met dysregulation in advanced malignancies and Non-Small Cell Lung Cancer (NSCLC). c-Met dysregulation will be determined by local/archival molecular pre-screening evaluations for eligibility of enrollment.
Mayo Clinic will be participating in both Part A (Phase 1) & (Phase 2) B of the study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Sani Kizilbash, M.D., M.P.H.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions