Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06090266
Status:
RECRUITING
Last Update Posted:
2023-11-02
First Post:
2023-09-29
Brief Title:
A Study of OR502 a Monoclonal Antibody Targeting LILRB2 Alone and in Combination With Anticancer Agents
Sponsor:
OncoResponse Inc
Organization:
OncoResponse Inc
Study Overview
Official Title:
A Phase 12 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies
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:
None
Brief Summary:
This is an open-label multicenter first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety tolerability pharmacokinetics pharmacodynamics and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors
Detailed Description:
This Phase 1-2 study is designed to determine the safety tolerability pharmacokinetics pharmacodynamics and preliminary anti-tumor activity of OR502 a fully human IgG1 antibody that binds specifically to LILRB2 in subjects with advanced solid tumors The study consists of two parts
Part A a dose-escalation phase to determine the maximum-tolerated dose MTD maximum achievable dose or optimal dose of OR502 for further evaluation as monotherapy and in combination with cemiplimab in a maximum of approximately 48 subjects
Part B an expansion phase in subjects with advanced solid tumors treated with OR502 at 2 separate doses as monotherapy followed by combination with cemiplimab and in subjects with previously treated platinum-resistant ovarian cancer PROC or cutaneous squamous cell carcinoma CSCC treated with OR502 at 2 separate doses in combination with cemiplimab Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety help determine the recommended Phase 2 dose RP2D for further development and determine preliminary anti-tumor activity Up to approximately 120 subjects total will be treated in Part B
Part A a dose-escalation phase to determine the maximum-tolerated dose MTD maximum achievable dose or optimal dose of OR502 for further evaluation as monotherapy and in combination with cemiplimab in a maximum of approximately 48 subjects
Part B an expansion phase in subjects with advanced solid tumors treated with OR502 at 2 separate doses as monotherapy followed by combination with cemiplimab and in subjects with previously treated platinum-resistant ovarian cancer PROC or cutaneous squamous cell carcinoma CSCC treated with OR502 at 2 separate doses in combination with cemiplimab Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety help determine the recommended Phase 2 dose RP2D for further development and determine preliminary anti-tumor activity Up to approximately 120 subjects total will be treated in Part B
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