A Trial to Find Out How Safe REGN5668 | Clinical Research Studies Listing

Recruiting

18-100 years

Female

Phase 1/2

326 participants needed

1 Location

Brief description of study

This study is divided into 2 parts (Escalation and Expansion). Your study doctor or study staff will also let you know you in what part of the study you will participate.

The purpose of Part 1 (Escalation) of the study is to find the highest, safe dose of the study drug(s), and to choose doses to study in more patients in Part 2 (Expansion). In Part 1 (Escalation), there will be multiple groups of patients, with each group receiving different doses of study drug(s). The time at which you join the study will determine the dose of study drug(s) you receive.

The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1 (Escalation) in additional patients to collect more information on safety and how well the study drug(s) work. In Part 2 (Expansion), up to 100 patients will get the doses of study drugs picked in Part 1 (Escalation).

The study drugs will be given to you as 1 of 2 separate combinations:

· REGN5668 + cemiplimab

· REGN5668 + REGN4018

The study doctor or study staff will let you know which treatment you will be receiving.

Detailed description of study

Patients who get REGN5668 and cemiplimab will be given REGN5668 (without cemiplimab) by intravenous infusion (IV, given into a vein) for up to 2 hours once per week. The study doctor may decide to split the dose of REGN5668 over 2 days. During the course of the study, patients may be asked to stay overnight in the hospital 2 times or more to monitor for side effects. The study doctor will patients know in advance if an overnight stay is needed.

Once the patient can receive cemiplimab, it will be given by IV over 30 minutes once every 3 weeks. On the days cemiplimab is given, the patient will be scheduled to get both REGN5668 and cemiplimab. During weeks cemiplimab, is not given the patient will get REGN5668 once a week.

For Patients who get REGN5668 and REGN4018, REGN4018 (without REGN5668) will be given by intravenous infusion (IV, given into a vein) for up to 4 hours once per week. REGN4018 may be given over 2 days every week. The doctor may decide to split the dose of REGN5668 and/or REGN4018 given over 2 days. Over the first few weeks, the dose of REGN4018 will be gradually increased. During the course of the study, patients may be asked to stay overnight in the hospital 5 times to monitor for side effects. The study doctor will let patients know in advance if overnight stays are needed.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer; Advanced or recurrent Endometrial cancer; Advanced or recurrent Uterine cancer
Age: Between 18 Years - 100 Years
Gender: Female

Key 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

Key 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

Updated on 01 Nov 2024. Study ID: 853971

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