What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly targeted therapies and immunotherapies, include agents like enzalutamide, sipuleucel-T, and lutetium Lu 177 vipivotide tetraxetan. Known side effects of these treatments can include fatigue, anemia, and bone marrow suppression. Enzalutamide often causes fatigue, anorexia, and nausea. Sipuleucel-T is generally well-tolerated but may not significantly improve overall survival. Lutetium Lu 177 vipivotide tetraxetan can lead to serious adverse effects such as high-grade bone marrow suppression and dry mouth. These side effects should be carefully considered when choosing a treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer that are similar to the investigational therapy LAVA-1207 include sipuleucel-T, an autologous cellular immunotherapy, and pembrolizumab, a PD-1 pathway inhibitor. Sipuleucel-T is used for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Pembrolizumab is approved for mCRPC patients with tumors exhibiting mismatch repair deficiency (dMMR) or high tumor mutational burden (TMB). These therapies aim to enhance the immune system's ability to target and destroy prostate cancer cells.

What other types of research exist?

Promising alternatives to LAVA-1207 for prostate cancer treatment in 2024 include: 1) Pembrolizumab (PD-1 inhibitor) which has shown durable responses in clinical trials, 2) Enzalutamide (androgen receptor inhibitor) combined with osteoclast inhibitors to reduce fracture risk, 3) Ra-223 (alpha-emitting radiopharmaceutical) combined with abiraterone or enzalutamide, and 4) BAT (Bipolar Androgen Therapy) which has shown potential in restoring sensitivity to prior therapies like abiraterone and enzalutamide.

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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

No Placebo-Only Group

Summary

This trial tests new treatments for advanced prostate cancer that doesn't respond to standard treatments. The treatments include a new drug, an immune system booster, and a medication that helps the immune system fight cancer.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 & Part 2: Frequency and severity of AEs

Part 1: Frequency and type of DLT

Secondary study objectives

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 study objectives

Exploratory Objective

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

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.