RecruitingPhase 1 / Phase 2

A Trial to Find Out if REGN5678 (Nezastomig) 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe REGN5678 (nezastomig) is and how well it works alone or with cemiplimab. It is for adults with prostate cancer that has spread and no longer responds to hormone-lowering treatment, or clear-cell kidney cancer that has spread. Researchers will first find safe doses, then test how well they shrink tumors.

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) 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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For the prostate cancer groups: Men must have prostate cancer confirmed by a tissue or cell test. It cannot be only the small-cell type.
  • For prostate cancer: PSA, a blood marker, must be at least 4 ng/mL at screening and must have risen within the past 6 months, as defined by the study.
  • For prostate cancer: You must have had at least 2 approved drug treatments, besides hormone-lowering treatment. These must include a newer hormone-blocking drug and a lutetium-based radiation drug that targets PSMA, a protein on cancer cells.
  • For the kidney cancer groups: Men and women must have kidney cancer with a clear-cell part, confirmed by a tissue or cell test.
  • For kidney cancer: The cancer must have spread, with at least one tumor that can be measured under study rules.
  • For kidney cancer: The cancer must have grown during or after at least one approved drug treatment for cancer that has spread. Prior treatment must include a PD-1 or PD-L1 immune drug, plus ipilimumab, a tyrosine kinase inhibitor (a drug that blocks growth signals), or both.
  • Other study entry rules also apply.

Who can't join

  • You received an approved whole-body cancer treatment within 3 weeks before study dosing, or still have more than mild side effects that have not returned to your usual level.
  • You received a whole-body biologic treatment too recently. The waiting period is 5 half-lives—the time it takes the drug level to drop by half five times.
  • You had treatment targeting PSMA before. For prostate cancer, PSMA-targeting radiation drugs are allowed.
  • In the dose-finding part, you had cancer immune treatment within 5 half-lives, except sipuleucel-T. In the later prostate cancer part, prior cancer immune treatment is excluded under study rules.
  • You need ongoing steroid medicine above 10 mg of prednisone daily, or an equal dose of another steroid, within 1 week before the first study dose.
  • You have, or had within 5 years, a serious disease where the immune system attacks the body that needed whole-body immune-suppressing treatment.
  • In the past year, you had brain inflammation, inflammation around the brain and spinal cord, uncontrolled seizures, or a disease that damages nerves over time. Mild dementia that does not affect daily activities is allowed.
  • You have uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosed condition that weakens the immune system.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: mCRPC cohorts (men): 1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma. 2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol. 3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy \[ADT\]) including at least: 1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide) 2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol ccRCC cohorts (men and women): 1. Histologically or cytologically confirmed RCC with a clear-cell component. 2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria 3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \[PD-1\]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor Key Exclusion Criteria: 1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol 2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol 3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC 4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy. 5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol 6. Any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy 7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol 8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \[ADLs\]) or uncontrolled seizures in the year prior to first dose of study therapy 9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study sites (24)

AZ

CA

CO

CT

FL

MA

MI

MN

NY

OH

OR

PA

RI

TX

VA

WV