Trial of LAVA-1207 in Patients with Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Interventions
- Biological: LAVA-1207Biological: LAVA-1207 plus Pembrolizumab
- Registration Number
- NCT05369000
- Lead Sponsor
- Lava Therapeutics
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2) LAVA-1207 LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2) LAVA-1207 plus Pembrolizumab LAVA-1207 LAVA-1207 plus Pembrolizumab LAVA-1207 LAVA-1207 LAVA-1207 LAVA-1207 plus Pembrolizumab LAVA-1207 plus Pembrolizumab LAVA-1207 plus Pembrolizumab
- Primary Outcome Measures
Name Time Method Part 1 & Part 2: Frequency and severity of AEs Approximately 24 months Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events and grading for CRS
Part 1: Frequency and type of DLT First 28 days of treatment DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment.illness, or concomitant medications and is occurring during the first 28 days of treatment.
- Secondary Outcome Measures
Name Time Method Part 1 & Part 2: Number of participants with an antitumor response Approximately 24 months According to immune Response Evaluation Criteria in Solid Tumors (RECIST and iRECIST) in patients with measurable disease.
Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies Approximately 6 months Development of antibodies (anti-drug antibodies) to LAVA-1207 will be evaluated
Part 1 & Part 2: Pharmacokinetic of LAVA-1207, area under the concentration versus time curve (AUC) Approximately 6 months Area under the plasma concentration versus time curve (AUC) of LAVA-1207 will be assessed in all patients
Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells Approximately 24 months Binding of LAVA-1207 to Vγ9Vδ2-T cells will be measured in whole blood
Trial Locations
- Locations (12)
UCSF Medical Center at Parnassus
🇺🇸San Francisco, California, United States
M Health Fairview University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center - Duke Cancer Center
🇺🇸Durham, North Carolina, United States
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