Spots Global Cancer Trial Database for A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours

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Trial Identification

Brief Title: A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours

Official Title: A Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumors

Study ID: NCT05607563

Conditions

Advanced Tumor

Interventions

PM1009 injection

Study Description

Brief Summary: The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009. PM1009 is a new novel fully human anti-TIGIT x PVRIG bispecific antibody, containing a wildtype IgG1 Fc and has high monovalent affinity to each target, it can binds to both TIGIT and PVRIG overexpressing target cells and binds to TIGIT and PVRIG simultaneously.

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 10 to 24 patients with advanced tumors. The dose expansion stage will be used safe and tolerable doses, with a planned enrollment of 30 patients with advanced tumors.