A Phase 1 and 2a open-label trial to evaluate the safety tolerability pharmacokinetics pharmacodynamics immunogenicity and antitumor activity of LAVA-1207 a PSMA-targeting bispecific .d-T cell engager alone or with low dose interleukin-2 or Pembrolizumab in patients with therapy refractory metastatic castration resistant prostate cancer

Brief description of study

This trial is an open-label, multi-center, Phase 1 and 2a dose escalation trial with an expansion cohort to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with therapy refractory 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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