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 (NCT05125016)
Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: Stanford University Medical Center - Blake Wilbur Drive — Palo Alto, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Stanford University Medical Center - Blake Wilbur Drive — Palo Alto, California
- Yale University Hospital — New Haven, Connecticut
- Norton Cancer Institute — Louisville, Kentucky
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Roswell Park Cancer Institute — Buffalo, New York
- Atrium Health Levine Cancer Institute — Charlotte, North Carolina
- The Ohio State University James Cancer Hospital — Columbus, Ohio
- Penn Medicine University of Pennsylvania Health System — Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- MD Anderson Cancer Center — Houston, Texas
- Medical College of Wisconsin — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Castration-resistant Prostate Cancer
- A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer — San Francisco, California
- Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment — Tucson, Arizona
- ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC — Sacramento, California
- FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) — Duarte, California
- A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer — Duarte, California
- FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer — San Francisco, California
Explore by condition: All Metastatic Castration-resistant Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.