A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
REGN4336: Administered per the protocol
REGN5678: Administered per the protocol
Study summary
This study is researching an investigational drug called REGN4336 both alone or together with another investigational drug called REGN5678. The study is focused on participants with previously treated metastatic prostate cancer.
The main purpose of the study is to look at the safety, tolerability (how the body reacts to the drug) and effectiveness (how well the drug works to shrink tumors) of REGN4336 when given in combination with REGN5678.
The study has 2 parts. The purpose of Part 1 is to determine a safe dose(s) of REGN4336 to be given alone or in combination with REGN5678. Part 1 is known as the "dose escalation" phase.
The purpose of Part 2, (known as the "dose expansion" phase), is to use the doses of REGN4336 and REGN5678 selected in Part 1 to further test how well the combination treatment with REGN4336 and REGN5678 works to shrink tumors.
The study is looking at several other research questions, including:
* What side effects may happen from taking REGN4336 alone or in combination with REGN5678
* How well does REGN4336 in combination with REGN5678 reduce tumor size
* How much REGN4336 is in the blood at different times when it is given alone or in combination with REGN5678
* Does the body make antibodies against the study drugs (REGN4336 or REGN5678)
Eligibility
Primary outcome measure(s)
- Incidence of Dose-Limiting Toxicities (DLTs) — up to 21 days
Dose escalation - Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) — Up to 5 years
Dose escalation - Incidence and severity of Serious Adverse Events (SAEs) — Up to 5 years
Dose escalation - Incidence and severity of Adverse Events of Special Interest (AESIs) — Up to 5 years
Dose escalation - REGN4336 monotherapy concentrations in serum — Up to 5 years
Dose escalation - REGN4336 concentrations in serum in combination with REGN5678 — Up to 5 years
Dose escalation - Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR) — Up to 5 years
Dose expansion
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Stanford University Medical Center - Blake Wilbur Drive | Palo Alto | California | Recruiting |
| Yale University Hospital | New Haven | Connecticut | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Recruiting |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | Recruiting |
| Atrium Health Levine Cancer Institute | Charlotte | North Carolina | Recruiting |
| The Ohio State University James Cancer Hospital | Columbus | Ohio | Recruiting |
| Penn Medicine University of Pennsylvania Health System | Philadelphia | Pennsylvania | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Withdrawn |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
More Regeneron Pharmaceuticals trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05125016 on ClinicalTrials.gov ↗ ← All trials in the USA