UPCC 09821 Phase 1/2 Study of Regn4336 (A Psmaxcd3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Metastatic Castration-Resistant Prostate Cancer
Study of Investigational Medication for Metastatic Castration-Resistant Prostate Cancer
Brief description of study
This study is researching an investigational drug called REGN4336 both alone or together with another investigational drug called REGN5678. The study is focused on participants with previously treated metastatic prostate cancer.
The main purpose of the study is to look at the safety, tolerability (how the body reacts to the drug) and effectiveness (how well the drug works to shrink tumors) of REGN4336 when given in combination with REGN5678.
The study has 2 parts. The purpose of Part 1 is to determine a safe dose(s) of REGN4336 to be given alone or in combination with REGN5678. Part 1 is known as the "dose escalation" phase.
The purpose of Part 2, (known as the "dose expansion" phase), is to use the doses of REGN4336 and REGN5678 selected in Part 1 to further test how well the combination treatment with REGN4336 and REGN5678 works to shrink tumors.
The study is looking at several other research questions, including:
- What side effects may happen from taking REGN4336 alone or in combination with REGN5678
- How well does REGN4336 in combination with REGN5678 reduce tumor size
- How much REGN4336 is in the blood at different times when it is given alone or in combination with REGN5678
- Does the body make antibodies against the study drugs (REGN4336 or REGN5678)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Metastatic Castration-resistant Prostate Cancer
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Age: 18 years or above
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Gender: Male
Key Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
- Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening
≥4 ng/mL and that has progressed within 6 months prior to screening, according to at
least 1 of the following:
- 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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria 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 NOTE: Measurable disease per RECIST version 1.1 per local reading at screening is not an eligibility criterion for enrollment
- Has progressed upon or intolerant to ≥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 (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)
Key Exclusion Criteria:
- Has received treatment with an approved systemic biologic 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
- Has received any previous systemic biologic or anti-cancer immunotherapy within 5 half-lives of first dose of study therapy, as described in the protocol
- Has received prior Prostate-Specific Membrane Antigen (PSMA)-targeting therapy NOTE: Prior therapy with PSMA-targeting radioligand(s) (eg, 177Lu-PSMA-617) is permitted. However, a period of 12 weeks must elapse between the last dose of the PSMAtargeting radioligand and the first dose of study drug
- 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
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- 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
- Uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or diagnosis of immunodeficiency, as described in the protocol.
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
This study investigates the use of an investigational medication for individuals with metastatic castration-resistant prostate cancer. The purpose of this study is to understand the safety and effectiveness of the investigational medication when given alone or in combination with another investigational drug. The study is divided into two parts: Part 1 focuses on finding a safe dose of the investigational medication, while Part 2 aims to evaluate how well the combination treatment works to reduce tumor size.
Participants will receive the investigational medication either alone or with another investigational drug. Study procedures include monitoring the amount of the medication in the blood, observing any side effects, and checking if the body produces antibodies against the medications. The study will also assess tumor size to determine the treatment's effectiveness.
- Who can participate: Participants must have metastatic castration-resistant prostate cancer with a PSA level of 4 ng/mL or higher. They should have progressed after at least two prior systemic therapies, including one second-generation anti-androgen therapy.
- Study details: Participants will receive the investigational medication, either alone or in combination with another investigational drug, and their response to the treatment will be monitored. The study will involve checking blood levels of the medication and observing for any side effects.
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