Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
Study NCT ID:
NCT05972460
Status:
UNKNOWN
Last Update Posted:
2023-08-02
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IMM2510, a PD-L1 and VEGF Bispecific Fusion Protein, in Patients With Advanced Solid Tumors
Sponsor:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Organization:
Study Overview
Official Title:
IMM2510, a Multi-Center, Open-Label, Dose Escalation and Cohort Expansion Phase I Clinical Study for Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
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 trial is a first-in-human, open-label, multi-center, dose escalation phase 1a study followed by cohort expansion phase 1b study to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510, a PD-L1 and VEGF bispecific fusion protein, in patients with advanced solid tumors.
Detailed Description:
IMM2510 is administered via intravenous infusion every 2 weeks up to 52 weeks. Phase 1a Dose Escalation: using accelerated titration followed by 3+3 dose escalation design to explore the maximum tolerated dose (MTD) and the recommended dose (RDE). Phase 1b Cohort Expansion: planing to enroll at least 60 patients with different advanced solid tumors (multiple cohorts) to further observe the safety and antitumor activity of IMM2510, and to determine the recommended phase II dose (RP2D).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: