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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.
(SPARTA) 1474095
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
(Adult, Older Adult) Male and Female 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 18 years & older
 
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
  • Advanced Solid Tumor
  • Neoplasms, Glandular and Epithelial
  • Adenocarcinoma
  • Pulmonary Disease
  • APL-101-01
  • Recurrent Solid Tumor
  • Carcinoma
  • Relapsed Solid Tumor
  • Gastroenterology
  • Respiratory Tract Diseases
  • Kidney Diseases
  • Respiratory Tract Neoplasms
  • Kidney Neoplasms
  • Thoracic Neoplasms
  • Lung Diseases
  • Urogenital Neoplasms
  • Lung Neoplasms
  • Urologic Diseases
  • Neoplasms
  • Urologic Neoplasms
  • Neoplasms by Histologic Type
  • Oncology (Adult)
  • Neoplasms by Site
 
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:
- Oncology Clinical Trials KPNC
-707-651-2797
-Desiree.Goldstein@kp.org
-Hayward Medical Center


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