A Phase 1 and 2a trial of LAVA-1207 in patients with therapy refractory metastatic castration resistant prostate cancer

Brief description of study

The purpose of the study is to determine and investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207, a bi-specific antibody targeting PSMA and Gamma-Delta T cells, in patients with therapy refractory metastatic castration resistant prostate cancer (mCRPC). The trial starts with an open-label, dose-escalation part (Part 1) to determine the recommended Phase 2 dose (RP2D). The second part of the trial (Part 2) is an open-label expansion cohort at the RP2D and schedule, in which the number of patients will be expanded to confirm safety in a patient population with therapy refractory mCRPC with measurable disease.


Clinical Study Identifier: s21-00470
ClinicalTrials.gov Identifier: NCT05369000
Principal Investigator: David R. Wise.
Other Investigators: Scot Niglio, Victor Ricardo Adorno Febles, Hank Ng, Minas Platon Economides.


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