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Brief Title: Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer
Official Title: A Phase 1/2a 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
Study ID: NCT05369000
Brief Summary: This is a phase 1/2a, 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 and 2a 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States
NYU Langone Health, New York, New York, United States
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc), Nijmegen, Gelderland, Netherlands
Erasmus MC (Erasmus Universitair Medisch Centrum Rotterdam), Rotterdam, South Holland, Netherlands
Amsterdam UMC - VU Medisch Centrum (VUmc), Amsterdam,, , Netherlands
ICO Hospitalet (Hospital Duran i Reynals), Barcelona, , Spain
Hospital Universitartio 12 De Octubre, Madrid, , Spain
Centro Integral Oncologico Clara Campal (HM CIOCC), Madrid, , Spain
Name: Clinical Trials Management
Affiliation: Lava Therapeutics
Role: STUDY_DIRECTOR