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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
345
Administered as per the protocol
Administered as per the protocol
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGMayo Clinic
Phoenix, Arizona, United States
RECRUITINGUniversity of Arizona
Tucson, Arizona, United States
RECRUITINGJohn Wayne Cancer Institute (JWCI)
Santa Monica, California, United States
RECRUITINGSarah Cannon Research Institute (SCRI)
Denver, Colorado, United States
RECRUITINGYale University Hospital
New Haven, Connecticut, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGMoffitt Cancer Center - McKinley Drive
Tampa, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITING...and 11 more locations
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Dose Escalation Phase
Time frame: Through study completion, up to 5 years
Incidence and severity of Adverse Event of Special Interests (AESIs)
Dose Escalation Phase
Time frame: Through study completion, up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
Dose Escalation Phase
Time frame: Through study completion, up to 5 years
Number of participants with Grade ≥3 laboratory abnormalities
Dose Escalation Phase
Time frame: Through study completion, up to 5 years
Incidence of Dose-Limiting Toxicities (DLTs)
Dose Escalation Phase
Time frame: First dose through day 42 of last participant in each dose level
Concentration of REGN5678 in serum over time
Dose Escalation Phase
Time frame: Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
Dose Escalation Phase
Time frame: Through study completion, up to 5 years
Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)
Dose Expansion Phase - mCRPC cohort
Time frame: Through study completion, up to 5 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Dose Expansion Phase - ccRCC cohort
Time frame: Through study completion, up to 5 years
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
Dose Escalation Phase - mCRPC cohort
Time frame: Through study completion, up to 5 years
ORR per RECIST 1.1 criteria
Dose Escalation Phase - ccRCC cohort
Time frame: Through study completion, up to 5 years
Incidence and severity of TEAEs
Dose Expansion Phase
Time frame: Through study completion, up to 5 years
Incidence and severity of AESIs
Dose Expansion Phase
Time frame: Through study completion, up to 5 years
Incidence and severity of SAEs
Dose Expansion Phase
Time frame: Through study completion, up to 5 years
Number of participants with grade ≥3 laboratory abnormalities
Dose Expansion Phase
Time frame: Through study completion, up to 5 years
Concentration of REGN5678 in serum over time
Dose Expansion Phase
Time frame: Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
Dose Expansion Phase
Time frame: Through study completion, up to 5 years
Percentage of participants with ≥50% decline of PSA
Dose Escalation and Dose Expansion Phases - mCRPC cohorts
Time frame: Through study completion, up to 5 years
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Percentage of participants with ≥90% decline of PSA
Dose Escalation and Dose Expansion Phases- mCRPC cohorts
Time frame: Through study completion, up to 5 years
Presence or absence of antibodies against REGN5678
Dose Escalation and Dose Expansion Phases
Time frame: Through study completion, up to 5 years
Presence or absence of antibodies against cemiplimab
Dose Escalation and Dose Expansion Phases
Time frame: Through study completion, up to 5 years