APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    201
  • sponsor
    Apollomics Inc.
Updated on 29 May 2021
Investigator
Lynn Manlapaz-Espiritu
Primary Contact
Hong Kong United Oncology Centre (4.4 mi away) Contact
+94 other location
cancer
measurable disease
lung cancer
major surgery
solid tumors
c-MET
cancer chemotherapy
solid tumour
solid neoplasm
lung carcinoma

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

Description

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 nave, 1L)
  • Cohort A-2: NSCLC EXON 14 skip mutation (c-Met nave, 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)

Details
Condition Non-Small Cell Lung Cancer, Pulmonary Disease, urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Glioblastoma Multiforme, Lung Neoplasm, Malignant neoplasm of brain, Gastropathy, Gastric Cancer, Bronchial Neoplasm, Stomach Discomfort, Kidney Disease (Pediatric), Brain Tumor (Pediatric), Solid Tumors, Solid Tumor, Advanced Cancer, Solid Neoplasm, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Gastric Carcinoma, Solid Tumour, Kidney Cancer, Lung Cancer, Brain Cancer, Kidney Disease, Lung Disease, Stomach Cancer, Brain Tumor, Renal Cancer, Urologic Cancer, glioblastoma, cancer advanced, gastric cancers, nsclc, cancer, renal, carcinoma lung, lung carcinoma, brain tumors
Treatment CBT-101 Oral Capsules, APL-101 Oral Capsules (formerly CBT-101), APL-101 Oral Capsules
Clinical Study IdentifierNCT03175224
SponsorApollomics Inc.
Last Modified on29 May 2021

Eligibility

Yes No Not Sure

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 nave) for first line treatment, Cohort A-2: NSCLC EXON 14 skip mutation (c-Met nave) 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
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