Clinical trial NCT06787612: Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Official title: Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Platinum Resistance
Fallopian Tube Cancer
Primary Peritoneal Cancer
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-01-22
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer.

The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug and its experimental combinations
* How much study drug and fianlimab is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations


Eligibility criteria: Key Inclusion Criteria:

1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate organ and bone marrow function, as described in the protocol
5. Platinum-Resistant Ovarian Cancer, as described in the protocol

Key Exclusion Criteria:

1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug(s)
2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s)
3. Another malignancy that is progressing or requires active treatment, as described in the protocol
4. Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, as described in the protocol
5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
timeFrame: Up to 3 years
Secondary outcomes:
measure: Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria
timeFrame: Up to 3 years
measure: Complete Response (CR) rate by RECIST 1.1
timeFrame: Up to 3 years
measure: Disease Control Rate (DCR) by RECIST 1.1
timeFrame: Up to 3 years
measure: Duration Of Response (DOR) by RECIST 1.1
timeFrame: Up to 3 years
measure: Progression-Free Survival (PFS) by RECIST 1.1
timeFrame: Up to 3 years
measure: Incidence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria
timeFrame: Up to 3 years
measure: Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Up to 3 years
measure: TEAEs by Lee criteria
timeFrame: Up to 3 years
measure: Concentration of ubamatamab in serum over time
timeFrame: Up to 3 years
measure: Concentration of fianlimab in serum over time
timeFrame: Up to 3 years
measure: Incidence of anti-drug antibodies (ADA) to ubamatamab
timeFrame: Up to 3 years
measure: Titer of ADA to ubamatamab
timeFrame: Up to 3 years
measure: Incidence of ADA to fianlimab
timeFrame: Up to 3 years
measure: Titer of ADA to fianlimab
timeFrame: Up to 3 years
measure: Incidence of ADA to cemiplimab
timeFrame: Up to 3 years
measure: Titer of ADA to cemiplimab
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Cancer Institute Sioux Falls
state: South Dakota
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: