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Phase I/II Study of REGN5668 (MUC16 x CD28, A Costimulatory Bispecific) Administered In Combination With Cemiplimab or REGN4018 (MUC16 x CD3)
The main purposes of this study are to: Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to patients with ovarian cancer; Look for signs that the study drugs can treat ovarian cancer
Primary Objective: The primary objectives of the study are: In the Dose Escalation Phase: -To assess the safety, tolerability, and pharmacokinetics (PK) of REGN5668 alone and in separate combinations with cemiplimab or REGN4018, in order to determine a maximally tolerated dose(s) (MTD) or recommended phase 2 dose(s) (RP2D) these combinations. In the Dose Expansion Phase: -To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018, (separately by cohort and combination) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Secondary Objectives: The secondary objectives of the study are: In the Dose Escalation Phase: -To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) as determined by ORR by RECIST 1.1 In the Dose Expansion Phase: -To characterize the safety profile in each expansion cohort -To characterize the PK of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) In both the Dose Escalation and Dose Expansion Phases: -To assess preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separated by cohort and combination) as measured by ORR based on immune based therapy (iRECIST), best overall response (BOR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) based on RECIST 1.1 and iRECIST -To assess changes in CA-125 levels from baseline after treatment with REGN5668 in combinations with cemiplimab or REGN4018 (separately by cohort and combination) -Immunogenicity of REGN5668, alone and in combinations with cemiplimab or REGN4018 Exploratory Objectives: The exploratory objectives of the study are: -To evaluate biomarkers that may correlate with mechanism of action, increased understanding of disease/on-target activity, observed toxicity, and potential anti-tumor activity, or markers that may be predictors of efficacy and/or safety, which may include but are not limited to: -MUC16 and programmed cell death-ligand 1 (PD-L1) expression in tumors -Intratumoral and circulating immune cell populations -Plasma cytokine, chemokines and other circulating proteins -Intratumoral gene/transcript expression, tumor and circulating gene mutational burden -Where possible, to evaluate the relationship between exposure and efficacy, biomarker and safety endpoints -To assess overall survival (OS)
Immunotherapy; Therapy (NOS)
Cemiplimab (); REGN2810 (Cemiplimab); REGN4018 (); REGN5668 ()
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