NCT07154290招募中2 期
A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
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
- 300
- 试验地点
- 17
- 主要终点
- Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
This study will evaluate two study drugs called ubamatamab and marlotamig, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), and sarilumab, to evaluate to see if it can help with immune-related side effects from ubamatamab.
The study is looking at:
- How well ubamatamab and marlotamig work(s)
- The side effects that ubamatamab and marlotamig might cause
- How much ubamatamab and marlotamig is in the blood at different times
- If the body makes antibodies to ubamatamab and/or marlotamig, this may cause the ubamatamab to not work as well
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
- All
- 接受健康志愿者
- 否
入选标准
- •Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC
- •Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol
- •If platinum doublet chemotherapy was not administered as first line therapy, it is required in a later line of therapy prior to enrollment unless there is a documented reason why it is not appropriate
- •Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol
- •Has at least 1 radiographically measurable lesion by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST v1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
- •Experienced toxicity related to prior treatment that has not resolved to grade 1 prior to initiation of study intervention (except alopecia, hearing loss, grade 2 neuropathy, or endocrinopathy managed with hormone replacement therapy)
- •Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
- •Current participation OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical study
- •Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention
- •Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol
- •Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention
- •Has received an anti-EGFR antibody therapy within the following drug-specific window prior to first dose of study intervention (approximately 5 half-lives), as described in the protocol
- •NOTE: Other protocol defined inclusion / exclusion criteria apply
研究组 & 干预措施
Arm 2B
Experimental
干预措施: Sarilumab (Drug)
Arm 1C
Experimental
干预措施: Marlotamig (Drug)
Arm 2B
Experimental
干预措施: Marlotamig (Drug)
Arm 1A
Experimental
干预措施: Sarilumab (Drug)
Arm 1B
Experimental
干预措施: Ubamatamab (Drug)
Arm 2C
Experimental
干预措施: Sarilumab (Drug)
Arm 2C
Experimental
干预措施: Marlotamig (Drug)
Arm 1B
Experimental
干预措施: Marlotamig (Drug)
Arm 1B
Experimental
干预措施: Sarilumab (Drug)
Arm 1C
Experimental
干预措施: Ubamatamab (Drug)
Arm 1C
Experimental
干预措施: Sarilumab (Drug)
Arm 2A
Experimental
干预措施: Ubamatamab (Drug)
Arm 2A
Experimental
干预措施: Sarilumab (Drug)
Arm 2B
Experimental
干预措施: Ubamatamab (Drug)
Arm 2C
Experimental
干预措施: Ubamatamab (Drug)
Arm 1A
Experimental
干预措施: Ubamatamab (Drug)
结局指标
主要结局
Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Up to 5 years
次要结局
- Severity of TRAEs(Up to 5 years)
- Incidence of ADA to marlotamig(Up to 5 years)
- Magnitude of ADA to marolotamig(Up to 5 years)
- Concentrations of marlotamig in serum(Up to 5 years)
- Occurrence of Treatment Emergent Adverse Events (TEAEs)(Up to 5 years)
- Severity of TEAEs(Up to 5 years)
- Occurrence of Treatment-Related Adverse Events (TRAEs)(Up to 5 years)
- Occurrence of Adverse Events of Special Interest (AESIs)(Up to 5 years)
- Severity of AESIs(Up to 5 years)
- Occurrence of Serious Adverse Events (SAEs)(Up to 5 years)
- Severity of SAEs(Up to 5 years)
- Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria(Up to 5 years)
- Duration of Response (DOR) as assessed by the investigator per RECIST v1.1(Up to 5 years)
- Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1(Up to 5 years)
- Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1(Up to 5 years)
- Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1(Up to 5 years)
- Incidence of Anti-Drug Antibodies (ADA) to ubamatamab(Up to 5 years)
- Magnitude of ADA to ubamatamab(Up to 5 years)
- Concentrations of ubamatamab in serum(Up to 5 years)
研究者
研究点 (17)
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