Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
MALE
NCT06085664

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

Led by M.D. Anderson Cancer Center · Updated on 2026-05-05

42

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male, 18 years or older
  • Prostate adenocarcinoma with Gleason score 8 or higher in at least 3 biopsy samples
  • At least 8 mm of disease in one biopsy core with Gleason 8 or greater
  • Prostate biopsy done within 3 months before screening and reviewed at MD Anderson Cancer Center
  • ECOG performance status of 0 or 1
  • No signs of metastatic disease on bone scan and CT or MRI within 60 days before enrollment
  • Localized or locally advanced prostate cancer suitable for surgery
  • Candidate for radical prostatectomy plus pelvic lymph node dissection
  • No previous prostate cancer treatment except transurethral resection of the prostate (TURP)
  • Hemoglobin level 11 g/dL or higher
  • Absolute neutrophil count 1.5 x 10^9/L or higher
  • Platelet count 100 x 10^9/L or higher
  • Serum creatinine ≤ 1.5 times upper limit of normal or estimated glomerular filtration rate over 50 mL/min/1.73 m²
  • Total bilirubin ≤ 1.5 times upper limit of normal (except for Gilbert's syndrome with documented history)
  • AST, ALT, and alkaline phosphatase levels ≤ 2.5 times upper limit of normal
  • Consent to MD Anderson laboratory protocol PA13-0291
  • Willing and able to attend clinic visits and follow study procedures
  • Signed informed consent
  • Use condom during sexual activity while on study drug and for 3 months after last dose; use additional contraception if with woman of childbearing potential
  • No sperm donation during study drug use and for 3 months after last dose
Not Eligible

You will not qualify if you...

  • Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, estrogens (except 5-alpha reductase inhibitors), or LHRH agonists/antagonists
  • Currently in another interventional study
  • Use of systemic corticosteroids over 10 mg prednisone daily or other immunosuppressive drugs within 14 days before treatment
  • History or suspicion of autoimmune disease (except vitiligo, resolved childhood eczema, or clinically stable thyroid disease)
  • Active infection needing systemic treatment such as HIV, active hepatitis, or fungal infection (well-controlled HIV allowed)
  • Significant heart disease including recent heart attack or unstable angina within 6 months, arrhythmias, recent blood clots, severe heart failure, pericarditis, myocarditis, or endocarditis
  • Major implants or devices such as prosthetic heart valves, recent artificial joints within 12 months, or history of infection related to implants
  • Other cancers treated within 2 years (except certain skin or bladder cancers in remission)
  • Major surgery within 14 days before first study drug dose
  • Neurological diseases like encephalitis, meningitis, significant dementia, or uncontrolled seizures within past year
  • Lung diseases such as interstitial lung disease or active pneumonitis in past 5 years
  • Live vaccine within 4 weeks before starting study drug
  • Prior stem cell or organ transplants
  • Any condition that investigator feels would prevent study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Sumit Subudhi, MD, PHD

CONTACT

S

Sumit Sumit, MD, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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