Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Prostatic Neoplasms

Carcinoma, Renal Cell

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Cemiplimab

Antineoplastic Agents, Immunological

Participants will receive REGN5678 monotherapy for presumptive recommended phase 2 dose(s) (presumptive RP2D) identification

Note: Dose escalation on monotherapy lead-in of REGN5678 followed by combination therapy of REGN5678 with full dose cemiplimab is no longer actively enrolling new participants. The prophylactic use of sarilumab is no longer in use.

Participants will receive the REGN5678 presumptive RP2D(s)

Participants will receive REGN5678 monotherapy for presumptive RP2D identification

Note: Dose escalation on monotherapy lead-in of REGN5678 followed by combination therapy of REGN5678 with full dose cemiplimab is no longer actively enrolling new participants. The prophylactic use of sarilumab is no longer in use.

Administered at the assigned dose level (DL) by intravenous (IV) infusion or subcutaneous (SC) administration

REGN5678

Clinical Trials Administrator

Clinical Trials Management

The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab.

The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.

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

1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab
2. How REGN5678 alone or in combination with cemiplimab works in the body
3. How much REGN5678 and/or cemiplimab are present in the blood
4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression

All individual patient data (IPD) that underlie publicly available results will be considered for sharing

Dose Escalation and Dose Expansion Phases - mCRPC cohorts

Dose Escalation and Dose Expansion Phases- mCRPC cohorts

Dose Escalation and Dose Expansion Phases

Regeneron Pharmaceuticals

Participants will receive REGN5678 by vein over about 2 hours the first time you receive it.

Participants will be admitted to the hospital, where participants will be monitored for side effects. Other doses may be given over 30-90 minutes depending on how you handle the dose.

Participants will receive REGN5678 weekly for 6 weeks.

Piflufolastat F18

Sumit Subudhi, MD, PHD

Sumit Sumit, MD, PHD

Sumit K. Subudhi, MD, PHD

Sumit K Subudhi, MD, PHD

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

Primary Objectives:

• To evaluate safety and tolerability of REGN5678 (antiPSMAxCD28) in patients with high-risk, localized prostate cancer.

Secondary Objectives:

• To assess the proportion of patients who achieve pathological response with REGN5678 in men with high-risk, localized prostate cancer.

Exploratory Objectives:

* To evaluate immune responses in the prostate tumor microenvironment and peripheral blood after treatment with REGN5678 as compared to pre-treatment samples and untreated control samples.
* To evaluate efficacy of REGN5678 in men with high-risk, localized prostate cancer. To evaluate exploratory imaging biomarkers for REGN5678 by PSMA PET/CT and FDG PET/CT

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

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

M.D. Anderson Cancer Center

Antibodies

Antibodies, Bispecific

Immunoglobulins

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

Administered once by IV infusion as prophylaxis prior to REGN4336 IV

Sarilumab

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors	NCT03972657	Metastatic Cast... Clear Cell Rena...	REGN5678 Cemiplimab	18 Years -	Regeneron Pharmaceuticals
A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy	NCT06085664	Prostate Cancer Radical Prostat...	REGN5678 Piflufolastat F...	18 Years -	M.D. Anderson Cancer Center
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	NCT05125016	Metastatic Cast...	REGN4336 Cemiplimab REGN5678 Sarilumab	18 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for regn5678

Every month we try and update this database with for regn5678 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 regn5678

Every month we try and update this database with for regn5678 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 regn5678 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.