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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
Must not have
Patient has any active-, uncontrolled-, or suspected infection.
Unstable cardiovascular function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing or uncontrolled infections.
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My heart condition is unstable.
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I do not have any severe or uncontrolled health conditions.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments primarily include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth, and androgen receptor signaling inhibitors like enzalutamide and abiraterone, which block the cancer cells' ability to use androgens. Chemotherapy, such as docetaxel, kills rapidly dividing cells, including cancer cells. Radioligand therapy, like lutetium Lu 177 vipivotide tetraxetan, delivers targeted radiation to prostate-specific membrane antigen (PSMA)-positive cells. Immunotherapy, including agents like sipuleucel-T and pembrolizumab, enhances the immune system's ability to recognize and attack cancer cells. These treatments are crucial as they offer multiple strategies to control cancer progression, improve survival, and maintain quality of life for prostate cancer patients.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,083 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,398 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 plus Pembrolizumab, LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2), 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
~101 spots leftby Apr 2027
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