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PD-1 Inhibitor

REGN5678 +/- Cemiplimab for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol (mCRPC cohorts)

(mCRPC cohorts) 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 one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)

Must not have

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

Has received prior PSMA-targeting therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 5 years

Awards & highlights

Summary

This trial is testing a new drug, REGN5678, to see if it is safe and effective in treating prostate cancer. The study will also look at how well the drug is tolerated and how it works in the body.

Who is the study for?

This trial is for adults with advanced prostate cancer or renal cell carcinoma that has spread and resisted castration treatment. Participants must have a specific protein on their tumors, have tried certain therapies without success, and cannot have had prior PSMA-targeting therapy or recent biologic treatments. They should not be battling uncontrolled infections like HIV or hepatitis, nor have serious neurological conditions.

What is being tested?

The study tests REGN5678 alone and combined with Cemiplimab to see how they affect tumor size in patients with metastatic cancers. Part 1 finds safe doses of REGN5678; Part 2 checks the effectiveness at those doses. Sarilumab may also be given to some participants as part of the study.

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, flu-like symptoms such as fever and chills, fatigue, skin reactions, changes in blood pressure or heart rate, liver inflammation which might cause yellowing of skin/eyes (jaundice), immune system overactivity potentially affecting various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has spread, is resistant to hormone therapy, and my PSA is 4 or higher.

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I have prostate cancer and have had at least 2 treatments, including a newer hormone therapy.

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My cancer shows PSMA activity on a PET scan.

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My cancer has worsened after treatment with specific immune therapies and cancer drugs.

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I have metastatic kidney cancer with at least one tumor that can be measured.

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My prostate cancer is confirmed and not purely small cell type.

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My kidney cancer has been confirmed with a lab test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had cancer treatment within the last 3 weeks or am still recovering from its side effects.

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I have received treatment targeting PSMA before.

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I do not have an uncontrolled HIV, hepatitis B or C, or an immunodeficiency.

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I haven't taken high doses of steroids or similar medicines in the last week.

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I have previously received immunotherapy for my cancer.

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I haven't taken any biologic therapy recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of adverse event of special interests (AESIs)

Incidence and severity of serious adverse events (SAEs)

Incidence and severity of treatment-emergent adverse events (TEAEs)

+4 more

Secondary study objectives

Concentration of REGN5678 in combination with cemiplimab in serum over time

Concentration of REGN5678 in serum over time

Incidence and severity of AESIs

+9 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Hyperthyroidism

13%

Constipation

13%

Vomiting

13%

Nausea

13%

Diarrhoea

13%

Subcutaneous abscess

13%

Infusion related reaction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Trial Design

4Treatment groups

Experimental Treatment

Group I: mCRPC - dose expansion cohortExperimental Treatment2 Interventions

Participants will receive the REGN5678 presumptive RP2D(s)

Group II: mCRPC - dose escalation cohortExperimental Treatment2 Interventions

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.

Group III: ccRCC - dose expansion cohortExperimental Treatment2 Interventions

Participants will receive the REGN5678 presumptive RP2D(s)

Group IV: ccRCC - dose escalation cohortExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 13Eligibility criteria met