Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05746897
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2023-02-03
Brief Title:
A First-in-human Phase I Open-label Multicenter Study of NM1FAnti-PVRIG in Patients With Advanced Solid Tumors
Sponsor:
Hefei TG ImmunoPharma Co Ltd
Organization:
Hefei TG ImmunoPharma Co Ltd
Study Overview
Official Title:
A Phase 1 Study to Investigate the Safety Tolerability PharmacokineticsPharmacodynamics and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally AdvancedMetastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-01
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:
A Phase 1 Study to Investigate the Safety Tolerability PharmacokineticsPharmacodynamics and Antitumor Activity of NM1F as Monotherapy and in Combination with Pembrolizumab in Subjects with Locally AdvancedMetastatic Solid Tumors
Detailed Description:
This is a Phase 1 multicenter open-label two-parts FIH study to evaluate the tolerability safety PKPD and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab Keytruda in subjects with unresectable locally advanced or metastatic solid tumors
The study consists of two parts NM1F monotherapy dose escalation Phase 1a NM1F dose escalation in combination with a fixed dose of pembrolizumab Phase 1b For each subject in the two parts the study will include a screening period up to 28 days a treatment period 1 year and 2 years for Phase 1a and 1b respectively or until treatment discontinuation and a follow-up period
The study consists of two parts NM1F monotherapy dose escalation Phase 1a NM1F dose escalation in combination with a fixed dose of pembrolizumab Phase 1b For each subject in the two parts the study will include a screening period up to 28 days a treatment period 1 year and 2 years for Phase 1a and 1b respectively or until treatment discontinuation and a follow-up period
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