NCT05069935终止1 期
A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Define the Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.
详细描述
This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Subjects with locally advanced or metastatic disease who have progressed after at least one line of therapy and diagnosis of one of the following by treatment cohort:
- •Cohort A: The following solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved: cutaneous melanoma, non-small cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, tumor mutation burden-high ≥ 10 mutations/megabase], cutaneous squamous cell carcinoma, triple-negative breast cancer.
- •Cohort B: HER2+ breast cancer that has relapsed or progressed on trastuzumab and progressed on either pertuzumab or HER2-targeting antibody drug conjugate; HER2+ gastric cancer that has relapsed or progressed on trastuzumab-containing therapy; OR any other HER2+ solid tumor having progressed on at least one line of standard-of-care therapy. For any tumor type in this cohort, HER2 status must be documented by a U.S. Food and Administration (FDA) approved test to be ≥2+ IHC or Average HER2 copy number ≥4 signals per cell by in situ hybridization.
- •Cohort C: CRC having progressed following prior cetuximab treatment or has KRAS/NRAS mutation; HNSCC having progressed following prior cetuximab.
- •Capable of giving signed informed consent
- •Aged ~ 18 years old
- •Willingness to comply with study procedures and duration
- •Measurable disease per RECIST v1.1
- •For subjects with >1 measurable lesion by RECIST v1.1 that can be safely accessed, willingness to undergo tumor biopsy
- •Contraceptive use for women and men as defined in the protocol
排除标准
- •Pregnant or breast-feeding women
- •ECOG performance status greater than or equal to 2
- •Evidence of insufficient organ function
- •Clinically significant cardiovascular disease including left-ventricular ejection fraction < 45%
- •Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
- •Known active central nervous system (CNS) involvement by malignancy that hasn'thas not remained stable for at least 3 months following effective treatment for CNS disease
- •Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
- •Currently receiving or likely to require immunosuppressive therapy Active bacterial, fungal, or viral infections including hep B, Hep C or HIV Live vaccine within 6 weeks prior to start of lympho-conditioning
- •Known allergy to albumin (human) or DMSO
研究组 & 干预措施
Dose Escalation
Experimental
- Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved
- Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors
- Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)
干预措施: FT538 (Drug)
Dose Escalation
Experimental
- Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved
- Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors
- Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)
干预措施: Cyclophosphamide (Drug)
Dose Escalation
Experimental
- Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved
- Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors
- Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)
干预措施: Fludarabine (Drug)
Dose Escalation
Experimental
- Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved
- Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors
- Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)
干预措施: Monoclonal antibody - Dose Escalation (Combination Product)
Dose Expansion
Experimental
- Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC))
- Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC)
- Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors
- Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC
Subjects with UC may be enrolled in the randomized expansion cohorts as follows:
- Cohort A, Arm R1: FT538 plus avelumab
- Cohort A, Arm R2: FT538 plus atezolizumab
干预措施: FT538 (Drug)
Dose Expansion
Experimental
- Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC))
- Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC)
- Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors
- Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC
Subjects with UC may be enrolled in the randomized expansion cohorts as follows:
- Cohort A, Arm R1: FT538 plus avelumab
- Cohort A, Arm R2: FT538 plus atezolizumab
干预措施: Cyclophosphamide (Drug)
Dose Expansion
Experimental
- Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC))
- Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC)
- Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors
- Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC
Subjects with UC may be enrolled in the randomized expansion cohorts as follows:
- Cohort A, Arm R1: FT538 plus avelumab
- Cohort A, Arm R2: FT538 plus atezolizumab
干预措施: Fludarabine (Drug)
Dose Expansion
Experimental
- Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC))
- Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC)
- Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors
- Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC
Subjects with UC may be enrolled in the randomized expansion cohorts as follows:
- Cohort A, Arm R1: FT538 plus avelumab
- Cohort A, Arm R2: FT538 plus atezolizumab
干预措施: Monoclonal antibody - Dose Expansion (Combination Product)
结局指标
主要结局
Define the Recommended Phase 2 Dose (RP2D)
时间窗: Up to ~1.5 years
To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
Incidence and Severity of Adverse Events (AEs)0
时间窗: Up to ~5 years
To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
次要结局
未报告次要终点
研究者
研究点 (4)
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