What is the mechanism of action of this treatment?

Prostate cancer treatments often target specific pathways to inhibit tumor growth and progression. Androgen deprivation therapy (ADT) reduces androgen levels, which prostate cancer cells rely on for growth. Abiraterone and enzalutamide further inhibit androgen receptor signaling. Immunotherapies like sipuleucel-T stimulate the patient's immune system to attack cancer cells. Bispecific antibodies, such as AMG 340, engage T-cells to target prostate-specific membrane antigen (PSMA) on cancer cells, enhancing the immune response against the tumor. These mechanisms are crucial as they offer targeted approaches to manage and potentially eradicate cancer cells, improving outcomes and quality of life for prostate cancer patients.

What side effects are associated with this type of intervention?

Common treatments for metastatic castrate-resistant prostate cancer (mCRPC) include PSMA-targeted therapies, androgen receptor signaling inhibitors, and taxane-based chemotherapies. Known side effects of these treatments can include fatigue, nausea, anemia, elevated transaminases, anorexia, rash, constipation, thrombocytopenia, vomiting, and diarrhea. Specific to PSMA-targeted therapies like lutetium Lu 177 vipivotide tetraxetan, side effects may also include bone marrow suppression, dry mouth, and nephrotoxicity. These treatments are generally well tolerated but can have serious adverse effects such as high-grade bone marrow suppression and other treatment-emergent adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen receptor pathway inhibitors like enzalutamide and abiraterone, taxane-based chemotherapies such as docetaxel and cabazitaxel, and radioligand therapies like lutetium Lu 177 vipivotide tetraxetan. While specific approvals for PSMA-targeted bispecific antibodies like AMG 340 are not mentioned, the approval of lutetium Lu 177 vipivotide tetraxetan, a PSMA-targeted radioligand, indicates a growing interest in PSMA-targeted therapies for metastatic castration-resistant prostate cancer (mCRPC).

What other types of research exist?

Promising novel alternatives to AMG 340 for prostate cancer patients in 2024 include: 1) Pembrolizumab, a PD-1 inhibitor, which has shown efficacy in various cancers including prostate cancer. 2) BAT (Bipolar Androgen Therapy), which has demonstrated potential in restoring sensitivity to androgen receptor-targeting therapies like enzalutamide and abiraterone. 3) Combination therapies involving CDK4 inhibitors like abemaciclib, which are being explored for their efficacy in advanced prostate cancer. Patients should discuss these options with their oncologist to determine the best course of action based on their specific medical condition.

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CAR T-cell Therapy

AMG 340 for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations

Must not have

Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed

Subject requires chronic immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

This trial is testing AMG 340, a new medicine that helps the immune system find and destroy cancer cells. It is aimed at patients with advanced prostate cancer who have not responded to at least two previous treatments. The study will determine the safest and most effective dose of AMG 340.

Who is the study for?

This trial is for individuals with metastatic castrate-resistant prostate cancer who have tried at least two systemic therapies. Participants must have a stable condition, including controlled HIV or hepatitis if present, and good heart, liver, bone marrow, and kidney function. Those with neuroendocrine differentiation in their cancer or other recent malignancies are excluded.

What is being tested?

AMG 340 is being tested in this phase 1 trial to assess its safety and effectiveness. The study has two parts: dose escalation to find the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), followed by a dose expansion to further evaluate the chosen dose's safety and pharmacokinetics.

What are the potential side effects?

As AMG 340 is an investigational drug targeting T-cells in prostate cancer treatment, potential side effects may include immune system reactions, infusion-related responses, fatigue, organ inflammation but specific side effects will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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I have had at least 2 treatments for metastatic prostate cancer and my cancer has gotten worse.

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I have been diagnosed with prostate cancer.

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My heart, liver, kidneys, and blood are all functioning well.

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I have undergone chemical or surgical castration.

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My cancer has spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer has spread to my brain or spinal cord.

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I am on long-term medication to suppress my immune system.

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I have a serious brain or spinal cord condition.

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My cancer has shown signs of neuroendocrine features.

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I have a history of serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Number of subjects with treatment-emergent adverse events (TEAEs)

Secondary study objectives

Anti-tumor activity by duration of objective response (DOR)

Anti-tumor activity by objective response rate (ORR)

Anti-tumor activity by progression free survival (PFS)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.

Group II: Dose EscalationExperimental Treatment1 Intervention

Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMG 340

2021

Completed Phase 1

~50

0 / 11Eligibility 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 often target specific pathways to inhibit tumor growth and progression. Androgen deprivation therapy (ADT) reduces androgen levels, which prostate cancer cells rely on for growth. Abiraterone and enzalutamide further inhibit androgen receptor signaling. Immunotherapies like sipuleucel-T stimulate the patient's immune system to attack cancer cells. Bispecific antibodies, such as AMG 340, engage T-cells to target prostate-specific membrane antigen (PSMA) on cancer cells, enhancing the immune response against the tumor. These mechanisms are crucial as they offer targeted approaches to manage and potentially eradicate cancer cells, improving outcomes and quality of life for prostate cancer patients.