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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 24 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 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 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
Other outcome measures
Exploratory Objective

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Group I: LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2)Experimental Treatment1 Intervention
LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2)
Group II: LAVA-1207 plus PembrolizumabExperimental Treatment2 Interventions
LAVA-1207 plus Pembrolizumab
Group III: LAVA-1207Experimental Treatment1 Intervention
LAVA-1207

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,906 Previous Clinical Trials
5,064,638 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,397 Patients Enrolled for Prostate Cancer
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 with Low-Dose Subcutaneous IL-2 (LDSC IL-2), LAVA-1207 plus Pembrolizumab, 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
~107 spots leftby Apr 2027