Safety and efficacy of APL-101 in NSCLC and advanced solid tumors
Research type
Research Study
Full 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
IRAS ID
273024
Contact name
Anna Minchom
Contact email
Sponsor organisation
Apollomics, Inc.
Eudract number
2019-001757-54
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 131,638
Duration of Study in the UK
2 years, 9 months, 29 days
Research summary
c-Met is a protein that is frequently changed in cancers. Cancer cells often use this changed protein to stimulate cell growth and escape therapies; therefore, this protein is considered to be an important target for cancer therapies.
This study involves research about the study of an investigational medication, APL-101. APL-101 is a small molecule agent which binds to the c-Met protein and hinders its function and is expected to cause death of the tumour cells overexpressing c-Met protein. The purpose of this study is to evaluate the safety and effectiveness of APL-101 for the treatment of individuals with Non-Small Cell Lung Cancer (NSCLC) with c-Met EXON 14 Skip Mutations and advanced solid tumours with c-Met dysregulation. A requirement for participation in this study is confirmation of abnormal regulation of c-Met protein in participant's tumour.
There are two parts in the study, Phase 1 and Phase 2. Phase 1 (dose escalation) will determine the maximum dose that is safe and tolerable to the participants while Phase 2 (dose expansion) will determine the effectiveness of that dose. The participation in this study will depend on response and tolerability to study medication. Participants will remain on study treatment until disease progression, death or withdrawal of consent. It is anticipated that each participant will be on study treatment for an average of 12 months with outliers.
Study procedure consists of 4 periods; screening, study treatment cycles, 30-day follow up and long term follow up. Each study treatment cycle will last 28 days and during these cycles, the participants will take the study drug orally on a daily basis.
The study will take place at approximately 100 different study sites in North America, Europe, and Asia, and about 201 patients will be enrolled. Approximately 2 UK study sites will participate in the study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0745
Date of REC Opinion
1 Jun 2020
REC opinion
Favourable Opinion