First-in-Human, Phase I/II Dose Escalation and Expansion Study of Zelenectide Pevedotin in Patients With Advanced Solid Tumors: Results From Monotherapy Dose Escalation.

ABSTRACT:

Purpose

Zelenectide pevedotin (BT8009) is a Bicycle Drug Conjugate comprising a highly selective Nectin-4-targeting Bicycle peptide, linked to monomethyl auristatin E. We report monotherapy dose-escalation results from Duravelo-1 (Phase I/II; ClinicalTrials.gov identifier: NCT04561362).

Methods

Adults with advanced/metastatic solid tumors associated with Nectin-4 expression received zelenectide pevedotin intravenously at 2.5, 5.0, or 7.5 mg/m² once weekly on a 28-day cycle; or 7.5 mg/m² on days 1 and 8 of a 21-day cycle; or 7.5 or 10.0 mg/m² once every 2 weeks on a 28-day cycle. Primary objectives were to evaluate safety and tolerability; antitumor activity and pharmacokinetic characterization were secondary objectives.

Results

Forty-n

SUBMITTER: Baldini C 

PROVIDER: S-EPMC12680284 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature