Clear Cell Renal Cell Carcinoma (ccRCC), Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Conditions
Keywords
Cemiplimab, PSMA, REGN4336, REGN15505, 4-1BB
Brief summary
This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells. The study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for: * Any side effects of study drugs * How well the study drugs work * How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times * If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected * What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination
Interventions
DRUGREGN15505
Administered per protocol
DRUGREGN15505+Cemiplimab
Administered per protocol
DRUGREGN15505+REGN4336
Administered per protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Participants with mCRPC: 1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma 2. mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol 3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol 4. 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 Participants with ccRCC: 5. Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component 6. Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria 7. Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)/ Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and/or a Tyrosine Kinase Inhibitor (TKI) Key
Exclusion criteria
For Both mCRPC and ccRCC Cohorts: 1. Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) 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 the protocol mCRPC Cohort Only: 2. Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617) Note: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Dose Limiting Toxicities (DLTs) | Up to 5 years | Dose Escalation |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to 5 years | Dose Escalation |
| Occurrence of Serious Adverse Events (SAEs) | Up to 5 years | Dose Escalation |
| Occurrence of Adverse Events of Special Interest (AESIs) | Up to 5 years | Dose Escalation |
| Composite Response (CompR) based on ≥50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic assessment of complete response (CR) or partial response (PR) | Up to 5 years | Dose Expansion-mCRPC |
| Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to 5 years | Dose Expansion-ccRCC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of TEAEs | Up to 5 years | Dose Expansion |
| Occurrence of SAEs | Up to 5 years | Dose Expansion |
| Occurrence of AESIs | Up to 5 years | Dose Expansion |
| CompR based on ≥50% decline of PSA from baseline and/or confirmed radiographic assessment of CR or PR | Up to 5 years | Dose Escalation-mCRPC |
| Percentage of participants with ≥50% reduction of PSA | Up to 5 years | Dose Escalation and Dose Expansion Phases - mCRPC cohorts |
| Percentage of participants with ≥90% reduction in PSA | Up to 5 years | Dose Escalation and Dose Expansion - mCRPC cohorts |
| Concentration of REGN15505 in serum | Up to 5 years | Dose Escalation and Expansion |
| Occurrence of Anti Drug Antibodies (ADA) against REGN15505 | Up to 5 years | Dose Escalation and Expansion |
| Occurrence of ADA against REGN4336 | Up to 5 years | Dose Escalation and Expansion |
| Magnitude of ADA against REGN15505 | Up to 5 years | Dose Escalation and Expansion |
| Magnitude of ADA against REGN4336 | Up to 5 years | Dose Escalation and Expansion |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed