NCT05950815

A Study of PM1015 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1015 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Biotheus Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

PM1015 is a specific antibody targeting CD73. This is a phase I study to evaluate the efficacy and safety of PM1015 in patients with advanced solid tumor.

Detailed description

This is a single-arm, open-label, Phase I study contains dose escalation stage and dose expansion stage. The dose escalation stage will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 13 to 24 patients with advanced tumors. The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 24 patients with advanced tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	CD73 Antigen	subjects will be administered with PM1015 via intravenously (IV) Q2W pemetrexed until progression or accepted other treatment.

Timeline

• Start date: 2022-05-10
• Primary completion: 2023-09-30
• Completion: 2024-09-30
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

1 site across 1 country: China