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Monoclonal Antibodies

Daratumumab + FMS Inhibitor for Prostate Cancer

Phase 1
Waitlist Available
Led By Sumit K Subudhi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection.
No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy.
Must not have
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists.
Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 18
Awards & highlights

Summary

This trial is testing the side effects of two drugs, daratumumab and FMS inhibitor JNJ-40346527, before surgery in treating patients with high-risk prostate cancer.

Who is the study for?
Men with high-risk, localized or locally advanced prostate cancer that can be surgically removed and have not had previous treatments for it. They must have a normal testosterone level, no metastatic disease, and be fit for surgery. Participants should agree to use condoms during sexual activity while on the study drug and for 3 months after the last dose.Check my eligibility
What is being tested?
The trial is testing daratumumab or FMS inhibitor JNJ-40346527 given before surgery to see if they improve outcomes in patients with high-risk prostate cancer. Daratumumab is an immunotherapy monoclonal antibody, while JNJ-40346527 blocks enzymes needed by tumor cells.See study design
What are the potential side effects?
Potential side effects include immune system reactions, possible organ inflammation due to daratumumab's action on the body's immune response, as well as risks associated with blocking cell growth enzymes from JNJ-40346527.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Immune changes in blood
Immune changes in tumor tissue
Pathological complete response (CR)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (FMS inhibitor JNJ-40346527)Experimental Treatment2 Interventions
Patients receive FMS inhibitor JNJ-40346527 PO BID for 4-5 weeks in the absence of disease progression or unacceptable toxicity. After a 3 day wash-out period, patients undergo radical prostatectomy.
Group II: Arm A (daratumumab)Experimental Treatment2 Interventions
Patients receive daratumumab IV over 4-8 hours once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy during week 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FMS Inhibitor JNJ-40346527
2017
Completed Phase 1
~40
Daratumumab
2014
Completed Phase 3
~2000
Radical Prostatectomy
2005
Completed Phase 2
~4550

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,246 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,368 Total Patients Enrolled
Sumit K SubudhiPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
31 Total Patients Enrolled
~4 spots leftby Jul 2025
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