Spots Global Cancer Trial Database for A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors

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Trial Identification

Brief Title: A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors

Official Title: A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of PBI-410 in Participants With Advanced Solid Tumors

Study ID: NCT06384807

Conditions

Solid Tumor

Interventions

PBI-410

Study Description

Brief Summary: This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410 in participants with previously treated, advanced solid tumors.

Detailed Description: This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410, a Trop-2 directed antibody-drug conjugate (ADC), in participants with previously treated, advanced solid tumors. The study comprises 2 parts: a Phase 1 Dose Escalation and a Phase 2 Dose Expansion. The Phase 1 will investigate the safety and tolerability of PBI-410 and identify one or more recommended doses for expansion (RDEs) and the maximum-tolerated dose (MTD) (if one exists). Phase 2 will investigate the preliminary efficacy of PBI-410 in signal-finding expansion cohorts.