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Androgen Receptor Antagonist

LAVA-1207 for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Lava Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.

Male patient with mCRPC with measurable or evaluable disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 months

Awards & highlights

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.

Who is the study for?

Men over 18 with advanced prostate cancer that hasn't responded to chemotherapy and certain hormone therapies. They must have a life expectancy of at least 6 months, be in fairly good physical condition (ECOG status of 0 or 1), and agree to use effective contraception. Men with active infections, immune disorders, unstable heart conditions, recent bisphosphonate treatment, or substance abuse issues cannot participate.Check my eligibility

What is being tested?

The trial is testing LAVA-1207's safety and how well it works for men whose prostate cancer has spread and resisted previous treatments. This early-phase study will gradually determine the best dose to minimize risks while assessing its effectiveness against the cancer.See study design

What are the potential side effects?

As this is an early-stage trial for LAVA-1207, specific side effects are not yet fully known but may include typical reactions related to cancer drugs such as nausea, fatigue, allergic responses or more serious complications depending on individual patient health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a male with advanced prostate cancer that can be measured or evaluated.

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I have tried and not responded to a taxane-based chemotherapy before.

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I have been treated with advanced hormone therapy for my cancer.

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My cancer is getting worse.

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I am fully active or can carry out light work.

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I am a man who has had a vasectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 & Part 2: Frequency and severity of AEs

Part 1: Frequency and type of DLT

Secondary outcome measures

Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells

Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies

Part 1 & Part 2: Number of participants with an antitumor response

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: LAVA-1207Experimental Treatment1 Intervention

In part 1 (dose escalation) LAVA-1207 will be administered via intravenous infusion with dose escalation In part 2 (dose expansion) patients will receive LAVA-1207 at the dose established in part 1 of the study

0 / 7Eligibility criteria met

Find a Location

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

537 Total Patients Enrolled

Media Library

LAVA-1207 (Androgen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05369000 — Phase 1 & 2

Prostate Cancer Research Study Groups: LAVA-1207

Prostate Cancer Clinical Trial 2023: LAVA-1207 Highlights & Side Effects. Trial Name: NCT05369000 — Phase 1 & 2

LAVA-1207 (Androgen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05369000 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer

2022. "Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05369000.