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Clinical Trials List

Protocol NumberR4018-ONC-2445
Not yet recruiting

2025-07-10 - 2029-08-30

Phase II

Recruiting7

ICD-10C56.1

Malignant neoplasm of right ovary

ICD-10C56.2

Malignant neoplasm of left ovary

ICD-10C56.9

Malignant neoplasm of unspecified ovary

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9183.0

Malignant neoplasm of ovary

Multi-arm Phase 2 Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) with or without Additional Agents in Platinum-Resistant Ovarian Cancer

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Regeneron Pharmaceuticals Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 康介乙 無
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張志隆 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 余慕賢 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Peng-Hui Wang 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳子和 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tzu-I Wu
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Platinum-Resistant Ovarian Cancer

Objectives

To assess the Objective Response Rate (ORR) of ubamatamab alone or in combination with bevacizumab, cemiplimab + fianlimab, or PLD (separately by study arm).

Test Drug

solultion

Active Ingredient

Ubamatamab
Sarilumab
DOXORUBICIN HYDROCHLORIDE
BEVACIZUMAB
Fianlimab and Cemiplimab

Dosage Form

27I
27I
27I
27I
27I

Dosage

MG/ML

Endpoints

ORR per Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 by investigator assessment

Inclution Criteria

1. Participants must have a histologically or cytologically confirmed advanced serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding leucocyte carcinoma, mucinous carcinoma, and carcinosarcoma).

2. There must be radiographic evidence of progression during prior therapy, and at least one measurable lesion that can be correctly measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (without prior radiation exposure).

3. An East Coast Cancer Clinical Research Consortium (ECOG) performance status score of 0 or 1.

4. Adequate organ and bone marrow function during the screening period, detailed in the program description.

5. Platinum-resistant ovarian cancer, detailed in the program description.

Note: In addition to the criteria listed here, other inclusion criteria defined in the program description also apply.

Exclusion Criteria

1. Underwent a major surgical procedure or experienced a major trauma within 4 weeks prior to the first dose of the investigational drug.

2. Data shows a history of allergic or acute allergic reactions attributable to antibody therapy, doxorubicin hydrochloride, or any component of the investigational drug.

3. Another malignant tumor that is progressing or requires aggressive treatment; details are provided in the program description.

4. Untreated or active primary brain tumor, central nervous system (CNS) metastasis, or spinal cord compression.

5. Has moderate to extensive ascites requiring ≥2 paracentesis procedures within 28 days prior to the first dose of therapy.

Note: In addition to the criteria currently listed, other exclusion criteria defined in the program description also apply.

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    220 participants

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