Dose Escalation/Expansion Study of PT199 (an Anti-CD73 mAb) Administered Alone and in Combination With a PD-1 Inhibitor (the MORNINGSTAR Study)

Non Small Cell Lung Cancer Clinical Trial

Official title: A Phase I, First-in-Human, Open-Label, Dose Escalation and Expansion Study of PT199 Administered Alone and in Combination With a PD-1 Inhibitor in Adult Patients With Advanced Solid Tumors.

Status Recruiting

Clinical Trial Summary

This is a first-in-human, Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT199 (an Anti-CD73 mAb) alone and in combination with a PD-1 inhibitor, in patients with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.

Clinical Trial Description

PT199 is an anti-CD73 mAb with a differentiated mechanism of action. PT199 is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment, rendering anti-tumor immune cells to be more responsive to checkpoint immunotherapies, such as PD-1/PD-L1 inhibitors. PT199 fully inhibits both soluble and membrane-bound CD73, unlike some other CD73 inhibitors which may inhibit only one form of enzyme or exhibit incomplete inhibition. Moreover, at higher concentrations no loss of inhibition or "hook effect" is observed with PT199. PT199 is a highly selective mAb, and thus far in development no off-target effects or dose limiting toxicities in cynomolgus monkey safety studies have been observed. Hence, PT199 addresses the limitations of current CD73 inhibitors and is expected to increase antitumor immune activation, especially in combination with PD-1 pathway inhibition, and thus offer a new treatment option for cancer patients. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Non Small Cell Lung Cancer
• Pancreatic Ductal Adenocarcinoma

• NCT number: NCT05431270
• Study type: Interventional
• Source: Phanes Therapeutics
• Contact: Phanes Therapeutics
• Phone: 858-766-0852
• Email: clinical-trials@phanestx.com
• Status: Recruiting
• Phase: Phase 1
• Start date: August 11, 2022
• Completion date: August 2025