NCT05972460

IMM2510, a PD-L1 and VEGF Bispecific Fusion Protein, in Patients With Advanced Solid Tumors

IMM2510, a Multi-Center, Open-Label, Dose Escalation and Cohort Expansion Phase I Clinical Study for Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	IMM2510	IMM2510 is administered intravenously every 2 weeks, every 28 days for a treatment cycle.

Timeline

• Start date: 2021-08-18
• Primary completion: 2023-12-01
• Completion: 2024-10-01
• First posted: 2023-08-02
• Last updated: 2023-08-02

Locations

4 sites across 1 country: China