Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-26 @ 1:47 PM
Study NCT ID:
NCT05142592
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2021-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
Sponsor:
Nanjing Immunophage Biotech Co., Ltd
Organization:
Study Overview
Official Title:
A Phase 1/2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-03
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 a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors.
The study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a).
Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.
The study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a).
Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: