Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03175224
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2017-06-01
Brief Title:
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Sponsor:
Apollomics Inc
Organization:
Apollomics Inc
Study Overview
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 Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARTA
Brief Summary:
To assess
efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations NSCLC harboring MET amplification solid tumors harboring MET amplification solid tumors harboring MET fusion primary CNS tumors harboring MET alterations solid tumors harboring wild-type MET with overexpression of HGF and MET
efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors EGFR-I
efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations NSCLC harboring MET amplification solid tumors harboring MET amplification solid tumors harboring MET fusion primary CNS tumors harboring MET alterations solid tumors harboring wild-type MET with overexpression of HGF and MET
efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors EGFR-I
Detailed Description:
Phase 1 lead-in stage of this study enrollment has been completed
In this Phase 2 study efficacy safety and tolerability will be assessed in the following cohorts
Cohort A-1 NSCLC EXON 14 skip mutation previously untreated MET inhibitor naive c-Met naïve 1L
Cohort A-2 NSCLC EXON 14 skip mutation previously treated with 3 prior lines in unresectable or metastatic setting MET inhibitor naive c-Met naïve 23L
Cohort B NSCLC EXON 14 skip mutation previously treated with 3 prior lines in unresectable or metastatic setting MET inhibitor experienced c-Met experienced progressed on prior c-Met inhibitor
Cohort C basket of tumor types eg NSCLC upper gastrointestinal GI colorectal hepatobiliary cancer harboring MET amplification except for primary CNS tumors previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
Cohort C-1 NSCLC harboring MET amplification and wild-type epidermal growth factor receptor EGFR previously treated or untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
Cohort C-2 EGFR positive NSCLC harboring MET amplification as an acquired resistance documented response with first-line EGFR-Inhibitor PR or CR per RECIST 12 weeks radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy MET inhibitor naïve
Cohort D basket of tumor types except for primary CNS tumors harboring MET gene fusions eg NSCLC upper GI colorectal hepatobiliary cancer previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
Cohort E primary CNS tumors with MET alterations single or co-occurred MET fusion including PTPRZ1-MET ZM fusion MET Exon 14 skipping mutation or MET amplification previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines MET inhibitor naïve
Cohort F basket of tumor types harboring wild-type MET with over-expression of HGF and MET eg NSCLC upper GI colorectal hepatobiliary cancer or primary CNS tumors previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
In this Phase 2 study efficacy safety and tolerability will be assessed in the following cohorts
Cohort A-1 NSCLC EXON 14 skip mutation previously untreated MET inhibitor naive c-Met naïve 1L
Cohort A-2 NSCLC EXON 14 skip mutation previously treated with 3 prior lines in unresectable or metastatic setting MET inhibitor naive c-Met naïve 23L
Cohort B NSCLC EXON 14 skip mutation previously treated with 3 prior lines in unresectable or metastatic setting MET inhibitor experienced c-Met experienced progressed on prior c-Met inhibitor
Cohort C basket of tumor types eg NSCLC upper gastrointestinal GI colorectal hepatobiliary cancer harboring MET amplification except for primary CNS tumors previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
Cohort C-1 NSCLC harboring MET amplification and wild-type epidermal growth factor receptor EGFR previously treated or untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
Cohort C-2 EGFR positive NSCLC harboring MET amplification as an acquired resistance documented response with first-line EGFR-Inhibitor PR or CR per RECIST 12 weeks radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy MET inhibitor naïve
Cohort D basket of tumor types except for primary CNS tumors harboring MET gene fusions eg NSCLC upper GI colorectal hepatobiliary cancer previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
Cohort E primary CNS tumors with MET alterations single or co-occurred MET fusion including PTPRZ1-MET ZM fusion MET Exon 14 skipping mutation or MET amplification previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines MET inhibitor naïve
Cohort F basket of tumor types harboring wild-type MET with over-expression of HGF and MET eg NSCLC upper GI colorectal hepatobiliary cancer or primary CNS tumors previously treated or previously untreated but refused standard treatment or if treatment was unavailable or unfeasible 3 prior lines in unresectable or metastatic setting MET inhibitor naïve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None