NCT06787612招募中2 期
Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 297
- 试验地点
- 56
- 主要终点
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
研究概览
简要总结
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants 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, REGN10597 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
- •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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ and bone marrow function, as described in the protocol
- •Platinum-Resistant Ovarian Cancer, as described in the protocol
排除标准
- •Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
- •Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
- •Another malignancy that is progressing or requires active treatment, as described in the protocol
- •Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
- •Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
- •Moderate to large or ascites, as described in the protocol
- •Bowel obstruction within last 3 months or current need for parenteral nutrition
- •NOTE: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B
Experimental
干预措施: Bevacizumab (Drug)
Arm C
Experimental
干预措施: Sarilumab (Drug)
Arms E1/E2
Experimental
干预措施: Ubamatamab (Drug)
Arm B
Experimental
干预措施: Ubamatamab (Drug)
Arm D
Experimental
干预措施: PLD (Drug)
Arm B
Experimental
干预措施: Sarilumab (Drug)
Arms E1/E2
Experimental
干预措施: Sarilumab (Drug)
Arm A2
Experimental
干预措施: Ubamatamab (Drug)
Arms E1/E2
Experimental
干预措施: REGN10597 (Drug)
Arm A1
Experimental
干预措施: Sarilumab (Drug)
Arm C
Experimental
干预措施: Ubamatamab (Drug)
Arm C
Experimental
干预措施: Fianlimab (Drug)
Arm D
Experimental
干预措施: Ubamatamab (Drug)
Arm D
Experimental
干预措施: Sarilumab (Drug)
Arm A2
Experimental
干预措施: Sarilumab (Drug)
Arm A1
Experimental
干预措施: Ubamatamab (Drug)
Arm C
Experimental
干预措施: Cemiplimab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
时间窗: Up to 3 years
次要结局
- Occurrence of ADA to cemiplimab(Up to 3 years)
- Magnitude of ADA to cemiplimab(Up to 3 years)
- Concentration of ubamatamab in serum(Up to 3 years)
- Concentration of fianlimab in serum(Up to 3 years)
- Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab(Up to 3 years)
- Magnitude of ADA to ubamatamab(Up to 3 years)
- Occurrence of ADA to fianlimab(Up to 3 years)
- Magnitude of ADA to fianlimab(Up to 3 years)
- Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria(Up to 3 years)
- Duration of Response (DOR) by RECIST 1.1(Up to 3 years)
- Concentration of REGN10597 in serum(Up to 3 years)
- Occurrence of ADA to REGN10597(Up to 3 years)
- Magnitude of ADA to REGN10597(Up to 3 years)
- Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria(Up to 3 years)
- Complete Response (CR) rate by RECIST 1.1(Up to 3 years)
- Disease Control Rate (DCR) by RECIST 1.1(Up to 3 years)
- Progression-Free Survival (PFS) by RECIST 1.1(Up to 3 years)
- Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0(Up to 3 years)
- TEAEs by Lee criteria(Up to 3 years)
研究者
研究点 (56)
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