NCT06085664

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
1mo left

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Dec 2023Jun 2026

First Submitted

Initial submission to the registry

October 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

May 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

October 10, 2023

Last Update Submit

April 29, 2026

Conditions

Prostate CancerRadical Prostatectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (1)

REGN5678 (anti-PSMAxCD28)

EXPERIMENTAL

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.

Drug: REGN5678Drug: Piflufolastat F18

Interventions

REGN5678DRUG

Given by IV (vein)

Also known as: PYLARIFY
REGN5678 (anti-PSMAxCD28)
Piflufolastat F18DRUG

Given by IV (vein)

REGN5678 (anti-PSMAxCD28)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men ≥ 18 years of age
  • Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1
  • No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment
  • 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
  • Hemoglobin ≥ 11 g/dL
  • Absolute neutrophil count ≥ 1.5 x 10\^9/L
  • Platelet count ≥ 100 x 10\^9/L
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \> 50 mL/min/1.73 m\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria
  • Total bilirubin ≤ 1.5 x ULN
  • NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history
  • Aspartate aminotransferase (AST) ≤ 2.5 x ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Alkaline phosphatase (ALP) ≤ 2.5 x ULN
  • +4 more criteria

You may not qualify if:

  • 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
  • Currently enrolled in another interventional study
  • Concurrent treatment with systemic corticosteroids (prednisone dose \> 10 mg per day or equivalent) or other immunosuppressive drugs \< 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
  • History of or known or suspected autoimmune disease (exception\[s\]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)
  • Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled (undetectable viral load by HIV ribonuclecid acid \[RNA\] polymerase chain reaction \[PCR\]) and CD4 counts greater than 350 are permitted to participate
  • History of clinically significant cardiovascular disease including, but not limited to:
  • Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation
  • Clinically significant cardiac arrhythmia
  • Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation
  • Congestive heart failure (New York Heart Association class III-IV)
  • Pericarditis/clinically significant pericardial effusion
  • Myocarditis
  • Endocarditis
  • History of major implant(s) or device(s), including but not limited to:
  • Prosthetic heart valve(s)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Sumit K Subudhi, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumit Subudhi, MD, PHD

CONTACT

(713) 792-2830sksubudhi@mdanderson.org

Sumit Sumit, MD, PHD

CONTACT

(713) 792-2830sksubudhi@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 17, 2023

Study Start

December 4, 2023

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

May 5, 2026

Record last verified: 2026-01

Locations

US(1)