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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.
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Academic Medical Center at the University of Amsterdam
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AmsterdamNetherlandsCompleted
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted

This page is information, not medical advice. Discuss any trial with your doctor.