AMG 340 for Prostate Cancer

No longer recruiting at 6 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Immunosuppressants

Disqualifiers: Other malignancy, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AMG 340 for prostate cancer that has spread and no longer responds to standard hormone therapy. The goal is to determine the safety and effectiveness of AMG 340 for patients who have already tried at least two other treatments. The trial consists of two parts: the first part identifies the best dose, and the second part tests that dose further. Men with prostate cancer that has spread and continues to grow despite past treatments might be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how AMG 340 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AMG 340 is likely to be safe for humans?

Research has shown that AMG 340 has been tested in earlier studies to assess its safety for treating prostate cancer. This drug, an antibody, helps the immune system locate and destroy cancer cells. Although detailed safety information about AMG 340 isn't widely available yet, it is currently undergoing testing in an early-phase trial. This stage primarily evaluates how well participants tolerate the drug and identifies any potential side effects.

At this stage, the main focus is on ensuring safety. If the drug progresses to later phases, it usually indicates that early safety results are promising enough for further study. Researchers closely monitor participants for any adverse reactions to ensure their safety. Since this trial involves adjusting and expanding doses, it aims to find the most effective dose with the fewest side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AMG 340 for prostate cancer because it offers a novel approach compared to standard treatments like hormone therapy or chemotherapy. Unlike these traditional options, AMG 340 is designed to target specific pathways involved in cancer growth, potentially leading to more effective suppression of the disease. This targeted mechanism may also reduce side effects, offering a more tolerable treatment experience for patients. Additionally, AMG 340 is being explored in both dose escalation and dose expansion stages, allowing researchers to fine-tune its effectiveness and safety, which could pave the way for improved patient outcomes.

What evidence suggests that AMG 340 might be an effective treatment for prostate cancer?

Research shows that AMG 340 is a promising treatment for advanced prostate cancer that no longer responds to hormone therapy. This treatment targets a protein called PSMA, often found on prostate cancer cells, and aids the body's immune cells, known as T-cells, in attacking the cancer. Early results from previous studies have shown that AMG 340 can lower levels of prostate-specific antigen (PSA), a marker used to monitor prostate cancer. It also has the potential to shrink tumors in patients who have already tried other treatments. These findings suggest that AMG 340 could effectively treat advanced prostate cancer by using the body's immune system to target cancer cells. Participants in this trial will enroll in either a dose escalation arm to determine the maximum tolerated dose or a dose expansion arm to further evaluate the treatment's effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I have been diagnosed with prostate cancer.

Exclusion Criteria

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

I haven't had or been treated for another cancer that could affect this study in the last 2 years.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

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

Variable

Dose Expansion

An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established to further characterize the safety, tolerability, and pharmacokinetic (PK) profile

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• AMG 340

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 1 Intervention

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

Group II: Dose Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Teneobio, Inc.

Lead Sponsor

Trials

4

Recruited

490+

Published Research Related to This Trial

The combination of 177Lu-PSMA-617 and NOX66 is a safe and feasible treatment for men with metastatic castration-resistant prostate cancer (mCRPC), with 86% of patients showing a reduction in prostate-specific antigen (PSA) levels after treatment.

Patients experienced a median overall survival of 19.7 months, and factors like higher PSMA SUVmean were linked to better treatment responses, indicating potential biomarkers for predicting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

177Lu-PSMA-617 and Idronoxil in Men with End-Stage Metastatic Castration-Resistant Prostate Cancer (LuPIN): Patient Outcomes and Predictors of Treatment Response in a Phase I/II Trial. Pathmanandavel, S., Crumbaker, M., Yam, AO., et al.[2022]

In a study of 113 patients with prostate cancer, 68Ga-PSMA PET/CT demonstrated significantly higher sensitivity (96.2%) and accuracy (99.1%) for detecting skeletal metastases compared to traditional bone scintigraphy (73.1% sensitivity and 84.1% accuracy).

68Ga-PSMA PET/CT not only identified more bone lesions (91 vs. 61) but also revealed an additional 96 unexpected extraskeletal lesions, highlighting its superior capability in detecting both lytic and bone marrow metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT Replacing Bone Scan in the Initial Staging of Skeletal Metastasis in Prostate Cancer: A Fait Accompli? Lengana, T., Lawal, IO., Boshomane, TG., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e14587

Phase 1 clinical trial of AMG 340, a prostate-specific ... Secondary outcomes included prostate antigen specific (PSA) response and objective response per response evaluation criteria in solid tumors ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04740034

NCT04740034 | A Study of AMG 340 in Subjects With ... This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific ...

3. amgentrials.com amgentrials.com/study/?id=TNB585.001

A Study of AMG 340 in Subjects with Metastatic Castrate- ... This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11395298/

A PHASE 1 STUDY OF ACAPATAMAB, A HALF-LIFE ... Approximately 10%–20% of patients with PCa develop castration-resistant PCa (CRPC) within 5 years of follow-up (3). Most patients with CRPC ...

5. researchgate.net researchgate.net/publication/381167119_Phase_1_clinical_trial_of_AMG_340_a_prostate-specific_membrane_antigen_PSMA-targeted_T-cell_engager_with_a_novel_low-affinity_CD3_binding_domain_designed_to_mitigate_toxicity_for_the_treatment_of_meta

Phase 1 clinical trial of AMG 340, a prostate-specific ... In a first-in-human study, AMG 160 has demonstrated a manageable safety profile with preliminary efficacy in heavily pretreated patients. Enzalutamide and ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT03792841

Safety, Tolerability, Pharmacokinetics, and Efficacy of ... AMG 160 is a targeted half-life extended, bispecific T-cell engager (BiTE®) immune therapy that engages a patient's own T cells to kill prostate cancer cells ...

7. aacrjournals.org aacrjournals.org/clincancerres/article/30/8/1488/742131/A-Phase-I-Study-of-Acapatamab-a-Half-life-Extended

A Phase I Study of Acapatamab, a Half-life Extended, PSMA ... Median PSA progression-free survival (PFS) was 3.3 months [95% confidence interval (CI): 3.0–4.9], radiographic PFS per Prostate Cancer Clinical Trials Working ...