NCT05369000

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer

A Phase 1 Open-label Trial to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207, a PSMA-targeting Bispecific γδ-T Cell Engager, Alone or With Low Dose Interleukin-2 or Pembrolizumab, in Patients With Therapy Refractory mCRPC

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Lava Therapeutics · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, first-in-human study to evaluate Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer.

Detailed description

This trial is an open-label Phase 1 dose escalation trial with an expansion cohort to investigate the safety and tolerability of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory mCRPC. The trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).

Conditions

• Metastatic Castration Resistant Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LAVA-1207	In part 1 \& part 2 • LAVA-1207 will be administered via intravenous infusion.
BIOLOGICAL	LAVA-1207 plus Pembrolizumab	Pembrolizumab will be administered via intravenous infusion

Timeline

• Start date: 2022-01-17
• Primary completion: 2025-06-18
• Completion: 2025-06-18
• First posted: 2022-05-11
• Last updated: 2025-08-01

Locations

12 sites across 3 countries: United States, Netherlands, Spain

Regulatory

• FDA-regulated drug study