LAVA-1207 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NYProstate CancerLAVA-1207 - Biological
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for prostate cancer that has resisted other treatments. They are testing to see if it is safe and tolerable for humans.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Approximately 6 months

Approximately 6 months
Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells
Part 1 & Part 2: Frequency and severity of AEs
Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies
Part 1 & Part 2: Number of participants with an antitumor response
Part 1 & Part 2: Pharmacokinetic of LAVA-1207, area under the concentration versus time curve (AUC)
Day 28
Part 1: Frequency and type of DLT

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

LAVA-1207
1 of 1

Experimental Treatment

66 Total Participants · 1 Treatment Group

Primary Treatment: LAVA-1207 · No Placebo Group · Phase 1 & 2

LAVA-1207
Biological
Experimental Group · 1 Intervention: LAVA-1207 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 6 months

Who is running the clinical trial?

Lava TherapeuticsLead Sponsor
1 Previous Clinical Trials
102 Total Patients Enrolled
Clinical Trials ManagementStudy DirectorLava Therapeutics
4 Previous Clinical Trials
502 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor expects you to live for at least 6 more months.
You must use reliable birth control methods to avoid pregnancy during the study. This includes using male condoms with female partners and another effective form of contraception with a low failure rate.

Frequently Asked Questions

What is the maximum number of patients that can be enrolled in this clinical trial?

"The sponsor, Lava Therapeutics, needs to recruit 66 patients that fit the study's inclusion criteria from their various locations. Two notable sites are Washington University School of Medicine in St. Louis, Missouri and Huntsman Cancer Institute, University of Utah located in Salt Lake City." - Anonymous Online Contributor

Unverified Answer

Are people still able to sign up for this research program?

"That is correct. The information available on clinicaltrials.gov reveals that this research project, which was originally published on June 27th 2022, is still recruiting patients. In total, 66 individuals are needed for the study to be conducted at 4 different hospitals or clinics." - Anonymous Online Contributor

Unverified Answer

What is the purpose of this clinical trial?

"The primary objective of this clinical trial, as measured over a period of approximately 6 months, is to assess the frequency and type of DLT (defined as Development of antibodies (anti-drug antibodies) to LAVA-1207). In addition to the primary outcome, this study will also evaluate secondary outcomes including the incidence and prevalence of anti-LAVA-1207 antibodies (defined as Binding of LAVA-1207 to Vγ9Vδ2-T cells), biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells (defined as measuring the binding of" - Anonymous Online Contributor

Unverified Answer

Is this clinical trial available in more than one Canadian province?

"The trial is being conducted at Washington University School of Medicine in St. Louis, Missouri; Huntsman Cancer Institute, University of Utah in Salt Lake City, Utah; Moffitt Cancer Center in Tampa, Florida and 4 other locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.