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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,466 Previous Clinical Trials
1,401,454 Total Patients Enrolled
15 Trials studying Prostate Cancer
4,914 Patients Enrolled for Prostate Cancer
Teneobio, Inc.Lead Sponsor
3 Previous Clinical Trials
451 Total Patients Enrolled
Ben Buelow, MD, PhDStudy ChairTeneobio, Inc.
3 Previous Clinical Trials
482 Total Patients Enrolled
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
945,198 Total Patients Enrolled
10 Trials studying Prostate Cancer
4,819 Patients Enrolled for Prostate Cancer

Media Library

AMG 340 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04740034 — Phase 1
Prostate Cancer Research Study Groups: Dose Escalation, Dose Expansion
Prostate Cancer Clinical Trial 2023: AMG 340 Highlights & Side Effects. Trial Name: NCT04740034 — Phase 1
AMG 340 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04740034 — Phase 1
~9 spots leftby Dec 2025