Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03681951
Status:
TERMINATED
Last Update Posted:
2020-07-31
First Post:
2018-09-10
Brief Title:
First-time-in-human FTIH Study of GSK3145095 Alone and in Combination With Other Anticancer Agents in Adults With Advanced Solid Tumors
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Open-Label Study to Investigate the Safety Clinical Activity Pharmacokinetics and Pharmacodynamics of GSK3145095 Administered Alone and in Combination With Anticancer Agents Including Pembrolizumab in Adult Participants With Selected Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated following an internal review of the companys current research and development portfolio
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In an unbiased CRISPR screen RIPK1 was identified as a top gene contributing to immunotherapy resistance In addition RIPK1 has been reported to drive pancreatic oncogenesis In murine models inhibition of RIPK1 kinase activity in the pancreatic tumor microenvironment leads to the replacement of tumor-permissive myeloid infiltrates with innate cells that promote an effective antitumor response by adaptive cells The investigators hypothesize that inhibition of RIPK1 in human pancreatic cancer subjects will modulate the immune infiltrate to sensitize tumors to checkpoint blockade
Detailed Description:
Study 205013 is a Phase 1 FTIH study of GSK3145095 alone and in combination with other anticancer agents including pembrolizumab in subjects with pancreatic ductal adenocarcinoma PDAC and other selected tumors The study includes up to 4 parts Part 1 dose escalation will be conducted in approximately 30 adult subjects with advanced or metastatic PDAC using escalating doses of GSK3145095 as monotherapy only Part 2 will combine escalating doses of GSK3145095 with 200 milligram mg pembrolizumab Dose escalation of GSK3145095 will begin at least one level below the highest dose shown to have an acceptable toxicity profile in at least 3 subjects in Part 1 Part 2 may be conducted in a broader population of selected solid tumors using a combination of escalating doses of GSK3145095 and 200 mg pembrolizumab Part 3 will enroll subjects treated with one or more dose levels of GSK3145095 in combination with 200 mg pembrolizumab Part 4 will investigate the combination of additional anticancer agents with one or more doses of GSK3145095 identified as safe in Part 1 Up to approximately 220 subjects will be treated in the study Parts 1 and 2 will each treat up to approximately 30 subjects Parts 3 and 4 will treat up to approximately 160 subjects up to 80 subjects in each Part The total duration of the study is expected to last up to 2 years
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