Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Cemiplimab

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Administered once weekly (QW) by subcutaneous (SC) injection, or intravenous (IV) infusion

REGN4336

Administered concomitantly every 3 weeks (Q3W) by IV infusion

Administered concomitantly QW by IV infusion

REGN5678

Administered once by IV infusion as prophylaxis prior to REGN4336 IV

Sarilumab

Clinical Trials Administrator

Clinical Trial Management

This study is researching an investigational drug called REGN4336. Some participants may receive additional investigational drugs in combination with REGN4336. These additional drugs include REGN5678, cemiplimab and sarilumab.

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug) and effectiveness of REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678. REGN4336, cemiplimab and REGN5678 are a type of treatment for cancer called immunotherapy,and are intended to activate T-cells to attack cancer cells.

This study has 2 parts. The purpose of Part 1 is to determine a safe dose of REGN4336 when given alone or when given in combination with cemiplimab or REGN5678. The purpose of Part 2 is to use the REGN4336 dose(s) determined in Part 1 to further test how well REGN4336 works to shrink tumors either when given alone or in combination with cemiplimab or REGN5678.

This study is looking at several other research questions, including:

* What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678?
* How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678?
* Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?

The study contains 3 separate modules in parallel: monotherapy with REGN4336 (Module 1) and combination therapies: REGN4336 plus cemiplimab (Module 2) and REGN4336 plus REGN5678 (Module 3). All 3 modules contain independent dose escalation cohorts and up to 2 recommended phase 2 dose regimens during dose expansion.

A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer

Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Spots Global Cancer Trial Database for regn4336

Every month we try and update this database with for regn4336 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for regn4336

Every month we try and update this database with for regn4336 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for regn4336 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.