Phase 1/2 Study of REGN5668 (MUC16 X CD28, A Costimulatory Bispecific) Administered in Combination with Cemiplimab or REGN4018 (MUC16 X CD3)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Ira
Winer, MD, PhD, FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Primary Objectives

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

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 (separately by cohort and combination) as measured by ORR based on immune based therapy RECIST (iRECIST), best overall response (BOR), duration of response (DOR), disease control rate (DCR), and progressionfree survival (PFS) based on RECIST 1.1 and iRECIST
To assess changes in CA125 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

Eligibility

Inclusion Criteria:

Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol
Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
Has adequate organ and bone marrow function as defined in the protocol
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has a life expectancy of at least 3 months
Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol

Exclusion Criteria:

Prior anti-cancer immunotherapy as defined in the protocol
Recent treatment with anti-Programmed Cell Death (PD-1)/PDL-1 therapy
Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol
Prior treatment with a MUC16-targeted therapy
Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (including antibody drug conjugates)
Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug
Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
Has history of clinically significant cardiovascular disease as defined in the protocol
Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices