NCT05867771

A Study of PM1022 in Patients With Advanced Tumors

A Phase I/IIa Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1022 in Patients With Advanced Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Biotheus Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study incluces a phase I study to evaluate the tolerance, safety, pharmacokinetic characteristics and preliminary efficacy of PM1022 in patients with advanced tumors and a phase IIa study to investigate the efficacy of PM1022 in patients with advanced tumors.

Detailed description

PM1022 is a recombinant humanized anti-PDL1 and anti-TIGIT bispecific antibody. This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of PM1022 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.

Conditions

• Advanced Tumors

Interventions

Type	Name	Description
DRUG	PM1022	PM1022 Injection

Timeline

• Start date: 2022-04-11
• Primary completion: 2024-04-10
• Completion: 2025-04-10
• First posted: 2023-05-22
• Last updated: 2023-05-22

Locations

2 sites across 1 country: China