A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06085664
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN5678 — DRUG
    Given by IV (vein)
  • Piflufolastat F18 — DRUG
    Given by IV (vein)

Study Details

To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.

Key Dates

Start date
Dec 4, 2023
Status verified
Jan 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: REGN5678 (anti-PSMAxCD28)
    Participants will receive REGN5678 by vein over about 2 hours the first time you receive it. Participants will be admitted to the hospital, where participants will be monitored for side effects. Other doses may be given over 30-90 minutes depending on how you handle the dose. Participants will receive REGN5678 weekly for 6 weeks.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Sumit K. Subudhi, MD, PHD
[email protected]
713-792-2830
Sumit K. Subudhi, MD, PHD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
M D Anderson Cancer Center· Houston, TX

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