AMG 340 for Prostate Cancer

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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How does the drug AMG 340 differ from other prostate cancer treatments?

AMG 340 is unique because it targets the prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer cells, potentially offering a more targeted approach compared to traditional chemotherapy or hormonal therapies. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of prostate-targeted radiotherapy using (131) I-MIP-1095 in combination with radiosensitising chemotherapeutic drugs. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Assessment of Treatment Response by 99mTc-MIP-1404 SPECT/CT: A Pilot Study in Patients With Metastatic Prostate Cancer. [2019]

3. United States 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? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

99m Tc-MIP-1404-SPECT/CT for the detection of PSMA-positive lesions in 225 patients with biochemical recurrence of prostate cancer. [2018]

5. United States 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. [2022]