Subjects will receive PM1032 by intravenous administration.

PM1032 injection

Xiying Dong

Lihua Wu

Yong Li

Ye Guo

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1032 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1032.

PM1032 is a Bispecific Antibody Targeting CLDN18.2 and 4-1BB.

In dose escalation stage, three subjects will be enrolled at the protocol starting dose of PM1032 for 21 Days DLT observation, followed by same dose every 2 weeks (Q2W) until they meet the discontinuation criteria.

Dose escalation will proceed to the next dose level according to the 3+3 design.

Dose expansion stage of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose escalation stage.

Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors

A Phase I/IIa Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1032 in Patients With Advanced Solid Tumors

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

Occurrence of DLT after receiving PM1032 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
Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors	NCT05839106	Advanced Tumor	PM1032 injectio...	18 Years - 75 Years	Biotheus Inc.
Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors	NCT05839106	Advanced Tumor	PM1032 injectio...	18 Years - 75 Years	Biotheus Inc.

Spots Global Cancer Trial Database for pm1032 injection