NCT05369000CompletedPhase 1/2
LAVA1207-001/LAVA1207-002 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, alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer
LAVA1207-001/LAVA1207-002 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, alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Mar 2025
Brief summary (registry, in English)
Part 1 Dose Escalation for LAVA-1207 alone, LAVA-1207 plus LDSC IL-2, and LAVA-1207 plus pembrolizumab. To investigate the safety and tolerability of treatment in patients with therapy refractory mCRPC. To determine the preliminary RP2D in patients with therapy refractory mCRPC for LAVA-1207 monotherapy, for LAVA-1207 + LDSC IL-2, and for LAVA-1207 + pembrolizumab. Part 2 Expansion Cohort for LAVA-1207 alone and/or LAVA-1207 plus LDSC IL2, and/or LAVA-1207 plus pembrolizumab. To investigate the safety and tolerability at the RP2D in therapy refractory mCRPC patients with measurable and non-measurable disease.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 24 Jul 2024
- Start date
- 30 Nov 2021
- Lead sponsor
- LAVA Therapeutics N.V.
- Diseases
- Prostate cancer
- NCT number
- NCT05369000
- EU CT number
- 2024-515821-27-00
- EudraCT number
- 2021-001789-39
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 110
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Academic Medical Center at the University of Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Radboud Universitair Medisch Centrum (Radboudumc) Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.