Actively Recruiting
A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
Led by M.D. Anderson Cancer Center · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab
CONDITIONS
Official Title
A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men 18 years of age or older
- Histologically or cytologically confirmed prostate adenocarcinoma without pure small cell carcinoma
- Metastatic castration-resistant prostate cancer with disease progression after at least two systemic therapies including one second-generation anti-androgen therapy
- PSA progression, radiographic progression of soft tissue or bone lesions as per study criteria
- Prior approved PSMA-targeted therapies and immunotherapies allowed
- Either orchiectomy or ongoing luteinizing hormone-releasing hormone (LHRH) therapy with serum testosterone below 50 ng/dL and agreement to continue during study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function with specified blood counts
- Serum creatinine less than 1.5 times upper limit of normal (ULN) or estimated glomerular filtration rate above 50 mL/min/1.73 m2
- Adequate liver function within defined limits, with exceptions for Gilbert's syndrome
- Consent to laboratory protocols and ability to comply with clinic visits and study procedures including tumor tissue provision
- Signed informed consent
- Use of condoms during sexual activity while on study drug and for 6 months after, with additional contraception if partner is of childbearing potential
- No sperm donation while on study drug and for 6 months following last dose
You will not qualify if you...
- Currently receiving treatment in another interventional study
- Participation in an investigational drug study within 4 weeks before first dose
- Recent treatment with approved systemic therapy within 3 weeks or not recovered from acute toxicities except defined exceptions
- Radiation therapy or major surgery within 14 days before first dose or not recovered from related adverse events
- Previous systemic biologic therapy within 5 half-lives before first dose, except prior sipuleucel-T
- Unresolved immune-mediated adverse events within 3 months before study start, except well-managed endocrinopathies
- Active progressing malignancy requiring treatment, except certain treated skin or other tumors
- Concurrent systemic corticosteroids above prednisone 10 mg/day or other immunosuppressive drugs within 14 days prior to treatment
- History or suspected autoimmune disease except specific allowed conditions
- Active infection requiring systemic therapy such as HIV, hepatitis, or fungal infection
- Significant cardiovascular disease within 6 months prior to treatment
- Other prior malignancies within 2 years except certain treated cancers in remission
- Neurological conditions like encephalitis, meningitis, or uncontrolled seizures within the past year
- Interstitial lung disease or active pneumonitis within past 5 years
- Live vaccine administration within 4 weeks prior to study medication
- Prior allogeneic stem cell or organ transplantation or recent autologous stem cell transplant
- Any medical, psychological, or social condition that may interfere with study participation as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Bilal Siddiqui, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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