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 γδ-T cell engager, in patients with therapy refractory metastatic castration resistant prostate cancer
This trial is an open-label Phase 1 and 2a dose escalation trial with an expansion cohort to investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC.
Part 1 Dose Escalation
To investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC.
To determine the recommended Phase 2 dose (RP2D) of LAVA-1207 in patients with therapy refractory mCRPC.
Part 2 Expansion Cohort
To investigate the safety and tolerability of LAVA-1207 at the RP2D in therapy refractory mCRPC patients with measurable disease.
Part 1 Dose Escalation and Part 2 Expansion Cohort
To explore the preliminary antitumor activity of LAVA-1207.
To evaluate the pharmacokinetics of LAVA-1207.
To evaluate the pharmacodynamics of LAVA-1207.
To evaluate the immunogenicity of LAVA-1207.
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