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APL-101 Study for NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advance Solid Tumors
Overall Recruitment Status: Active, currently enrolling
 
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 Advance Solid Tumors
 
Region Sponsors
California - Northern
Apollomics, Inc.
 
Acronym KP IRB No.
1474095
 
Study Type Phase
Clinical Trial Phase I
 
Study Population Description
Individuals with histologically and / or cytological confirmed: Solid Tumor, Advanced Cancer, Renal Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, NSCLC, Lung Cancer.
 
Purpose
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 Advance Solid Tumors.
 
Detailed Description
This is a Phase 1, multi-center, 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 and Dose and Disease Expansion Cohorts. However, in the Dose and Disease Expansion Cohorts, the c-MET historical results will be confirmed by a central laboratory retrospectively, but will not be a determinant for study entry. 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, three 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 dysregulation (amplification or mutation or fusions).
 
Gender Age Limit
Male & Female
 
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, three 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 dysregulation (amplification or mutation or fusions)
  • Measurable disease according to RECIST v1.1. 7.
  • 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 CBT-101, excipients of the drug product, or other components of the study treatment regimen
  • Known mutation of EGFR, ALK or ROS1 or have received a kinase inhibitor for these mutations
  • History of, or at risk for, cardiac disease (e.g., long QTc syndrome [>/= 450 msec] or concurrent treatment with any medication that prolongs QT interval)
  • Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptic and requiring high doses of steroids
  • 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

 
Keywords and/or Specific Medical Conditions
  • Adenocarcinoma
  • Neoplasms, Glandular and Epithelial
  • Advanced Solid Tumor
  • Pulmonary Disease
  • Carcinoma
  • Recurrent Solid Tumor
  • Gastroenterology
  • Relapsed Solid Tumor
  • Kidney Diseases
  • Respiratory Tract Diseases
  • Kidney Neoplasms
  • Respiratory Tract Neoplasms
  • Lung Diseases
  • Thoracic Neoplasms
  • Lung Neoplasms
  • Urogenital Neoplasms
  • Neoplasms
  • Urologic Diseases
  • Neoplasms by Histologic Type
  • Urologic Neoplasms
  • Neoplasms by Site
  • Oncology (Adult)
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Leandro Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Gastroenterology
  • Oncology (Adult)
  • Pulmonary Disease


Principal Investigator:
Jennifer M Suga, MD
Contact Information:
- Desiree Goldstein
-707-651-2797
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


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