Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824975
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-03-28
Brief Title:
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors
Sponsor:
GI Innovation Inc
Organization:
GI Innovation Inc
Study Overview
Official Title:
An Open-label Multicenter Dose Escalation and Expansion Phase 12a Study to Evaluate the Safety Tolerability and Pharmacokinetics and Therapeutic Activity of GI-102 in Patients With Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to evaluate the safety tolerability pharmacokinetics and therapeutic activity of GI-102 as a single agent over a range of advanced andor metastatic solid tumors
Detailed Description:
This is a phase 12a open-label dose-escalation and expansion study to evaluate the safety tolerability and anti-tumor effect of GI-102 as a single agent over a range of advanced andor metastatic solid tumors This study is adaptive in nature While GI-102 is being investigated as a single agent in this trial GI-102 has the potential of being combined with other agents Based on the data from ongoing nonclinical studies and the dose escalation phase additional combination therapies GI-102 drugs X may be proposed and added to this study protocol via an amendment
This study will comprise two phases
GI-102 monotherapy dose escalation phase
GI-102 monotherapy dose expansion phase
GI-102 is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin IL-2 variant as a C-terminal moiety configurated via a human immunoglobulin G4 IgG4 Fc GI-102 has unique characteristics by having bispecificity to CD80 and IL2Rβγ The CD80 portion is responsible for targeting tumorimmune cells while blocking CTLA-4 expressed on the Treg cells The IL-2v of GI-102 is designed to abolish IL-2Rα affinity and therefore minimize the effect on Treg while it has very outstanding effect on NK and CD8 T cell proliferation and activity through IL-2Rbr affinity
This study will comprise two phases
GI-102 monotherapy dose escalation phase
GI-102 monotherapy dose expansion phase
GI-102 is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin IL-2 variant as a C-terminal moiety configurated via a human immunoglobulin G4 IgG4 Fc GI-102 has unique characteristics by having bispecificity to CD80 and IL2Rβγ The CD80 portion is responsible for targeting tumorimmune cells while blocking CTLA-4 expressed on the Treg cells The IL-2v of GI-102 is designed to abolish IL-2Rα affinity and therefore minimize the effect on Treg while it has very outstanding effect on NK and CD8 T cell proliferation and activity through IL-2Rbr affinity
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