RecruitingPhase 1

A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC

United States60 participantsStarted 2025-07-09

Plain-language summary

A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men .18 years of age.
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
✓. mCRPC with disease progression after at least two lines of systemic therapy, including one line of second-generation anti-androgen therapy, according to one of the following criteria:
✓. PSA progression as defined by a rising PSA level confirmed with an interval of \>1 week between each assessment.
✓. Radiographic disease progression in soft tissue based on RECIST Version 1.1 criteria with PCWG3 modifications with or without PSA progression.
✓. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
✓. Have had either orchiectomy OR be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone \<50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study.
✓. ECOG performance status (PS) grade of 0 or 1.

✕. Currently receiving treatment in another interventional study
✕. Has participated in a study of an investigational drug within 4-weeks of first dose of study therapy.
✕. 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 except for laboratory changes as described in inclusion criteria or patients with grade 2\< neuropathy.
✕. Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (ie, grade .1 or baseline) from AEs, except for laboratory changes as described in inclusion criteria or patients with grade .2 neuropathy.
✕. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy.
✕. Patients who have not recovered (ie, grade .1 or baseline) from immune-mediated AEs 3 months prior to initiation of study drug therapy except for endocrinopathies adequately managed with hormone replacement.
✕. Another malignancy that is progressing or requires active treatment, except:
✕. Non-melanoma skin cancer that has undergone potentially curative therapy

Safety and Adverse Events (AEs

Timeframe: Through study completion; an average of 1 year.

NCT IDNCT06826768

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Bilal Siddiqui, MD

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men .18 years of age.
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
✓. mCRPC with disease progression after at least two lines of systemic therapy, including one line of second-generation anti-androgen therapy, according to one of the following criteria:
✓. PSA progression as defined by a rising PSA level confirmed with an interval of \>1 week between each assessment.
✓. Radiographic disease progression in soft tissue based on RECIST Version 1.1 criteria with PCWG3 modifications with or without PSA progression.
✓. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
✓. Have had either orchiectomy OR be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone \<50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study.
✓. ECOG performance status (PS) grade of 0 or 1.

✕. Currently receiving treatment in another interventional study
✕. Has participated in a study of an investigational drug within 4-weeks of first dose of study therapy.
✕. 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 except for laboratory changes as described in inclusion criteria or patients with grade 2\< neuropathy.
✕. Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (ie, grade .1 or baseline) from AEs, except for laboratory changes as described in inclusion criteria or patients with grade .2 neuropathy.
✕. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy.
✕. Patients who have not recovered (ie, grade .1 or baseline) from immune-mediated AEs 3 months prior to initiation of study drug therapy except for endocrinopathies adequately managed with hormone replacement.
✕. Another malignancy that is progressing or requires active treatment, except:
✕. Non-melanoma skin cancer that has undergone potentially curative therapy