Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04977453
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2021-07-09
Brief Title:
GI-101 As a Single Agent or in Combination with Pembrolizumab Lenvatinib or Local Radiotherapy in Advanced Solid Tumors
Sponsor:
GI Innovation Inc
Organization:
GI Innovation Inc
Study Overview
Official Title:
A Phase 12 Open-label Dose-escalation and Expansion Study to Evaluate Safety Tolerability Pharmacokinetics and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors Keynote B59
Status:
RECRUITING
Status Verified Date:
2024-02
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-101GI-101A as a single agent or in combination with pembrolizumab lenvatinib or local radiotherapy RT over a range of advanced andor metastatic solid tumors
Detailed Description:
This is a phase 12 open-label dose-escalation and expansion study to evaluate the safety tolerability and anti-tumor effect of GI-101GI-101A as a single agent or in combination with pembrolizumab lenvatinib or local RT over a range of advanced andor metastatic solid tumors
This study will comprise six parts
Part A Dose-escalation and expansion cohorts of GI-101 monotherapy
Part B Dose-escalation and expansion cohorts of GI-101 plus pembrolizumab
Part C Dose-optimization and expansion cohorts of GI-101 plus lenvatinib
Part D Dose-optimization and expansion cohorts of GI-101 plus local RT
Part E Dose-escalation and expansion cohorts of GI-101A monotherapy
Part F Dose-escalation and expansion cohorts of GI-101A plus pembrolizumab
GI-101GI-101A 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-101A is an abbreviation of advanced GI-101 with an improved formulation for manufacture consistency
Drug Information available for Pembrolizumab httpswwwkeytrudahcpcom Lenvatinib httpwwwlenvimacom
This study will comprise six parts
Part A Dose-escalation and expansion cohorts of GI-101 monotherapy
Part B Dose-escalation and expansion cohorts of GI-101 plus pembrolizumab
Part C Dose-optimization and expansion cohorts of GI-101 plus lenvatinib
Part D Dose-optimization and expansion cohorts of GI-101 plus local RT
Part E Dose-escalation and expansion cohorts of GI-101A monotherapy
Part F Dose-escalation and expansion cohorts of GI-101A plus pembrolizumab
GI-101GI-101A 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-101A is an abbreviation of advanced GI-101 with an improved formulation for manufacture consistency
Drug Information available for Pembrolizumab httpswwwkeytrudahcpcom Lenvatinib httpwwwlenvimacom
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KEYNOTE-B59 | OTHER | Merck Sharpe and Dohme LLC | None |