Participants receive PM1009 intravenously, every 2 weeks

PM1009 injection

Xuelian Xing

Ye Guo

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.

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.

Patients sequentially receive PM1009 120 mg, 300 mg, 600 mg, 1200 mg, intravenously, Q2W

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

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

The data will be published or presented for publications (poster, abstract, articles or papers) or maked any presentations.

T-lymphocyte phenotypes in peripheral blood

Occurrence of DLT after receiving PM1009 injection

To determine the RP2D of PM1009 injection

To evaluate the Cmax of PM1009 monotherapy

To evaluate the Tmax of PM1009 monotherapy

To evaluate the Cmin of PM1009 monotherapy

To evaluate the Ctrough of PM1009 monotherapy

To evaluate the AUC0-last of PM1009 monotherapy

To evaluate the AUC0-tau of PM1009 monotherapy

To evaluate the t1/2 of PM1009 monotherapy

To evaluate the Rac_Cmax of PM1009 monotherapy

To evaluate the Rac_AUC of PM1009 monotherapy

Defined as the number of patients with best overall response of confirmed CR or PR per RECIST 1.1 divided by the patients with at least one tumour imaging evaluation

Defined as the percentage of patients who have achieved CR, PR, Non-CR/Non-PD, or SD in the study.

Defined as the time from the date of first dose of study drug to the first observation of documented disease progression per RECIST 1.1 as determined by the Investigators or death due to any cause, whichever occurs first.

Defined as the time from the date of first dose of study drug to the date of documented death due to any cause.

To evaluate the incidence of ADA to PM1009 injection

The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours	NCT05607563	Advanced Tumor	PM1009 injectio...	18 Years - 75 Years	Biotheus Inc.
A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours	NCT05607563	Advanced Tumor	PM1009 injectio...	18 Years - 75 Years	Biotheus Inc.

Spots Global Cancer Trial Database for pm1009 injection