NCT05397093终止1 期
A Phase 1a/1b, Open-Label, Multicenter Study Evaluating the Safety and Feasibility of ITIL-306 in Subjects With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Instil Bio
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)
研究概览
简要总结
ITIL-306-201 is a phase 1a/1b, multicenter, clinical trial evaluating the safety and feasibility of ITIL-306 in adult participants with advanced solid tumors whose disease has progressed after standard therapy. ITIL-306 is a cell therapy derived from a participant's own tumor-infiltrating immune cells (lymphocytes; TILs) and contains a unique molecule designed to increase TIL activity when it encounters folate receptor α (FOLR1) on the tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically documented advanced (metastatic and/or unresectable) disease as appropriate per cohort.
- •Phase 1a Dose Escalation: High-grade serous epithelial carcinoma of the ovary, fallopian tube, or peritoneum, adenocarcinoma of the lung, or clear-cell renal cell carcinoma.
- •Phase 1b Expansion:
- •Cohort 1: High grade serous, endometrioid, or clear cell epithelial carcinoma of the ovary, fallopian tube, or peritoneum.
- •Cohort 2: Squamous-cell carcinoma or adenocarcinoma of the lung.
- •Cohort 3: Clear cell or papillary RCC.
- •Disease must have unequivocally progressed during or after at least 1 prior line of systemic therapy that must include the following parameters (by indication):
- •Phase 1a dose escalation and Phase 1b Cohort 1: Participants with EOC whose disease has progressed during or after 1 prior line (at least 4 cycles) of platinum-based chemotherapy and had disease progression within 6 months from the last dose of the platinum agent. Participants who received 2 or more lines of platinum therapy must have disease which has progressed on or within 6 months after the date of the last dose of the platinum agent. Participants with BRCA-mutated EOC must have received previous PARP inhibitor therapy.
- •Phase 1a dose escalation and Phase 1b Cohort 2: Participants with NSCLC whose disease has progressed after 1 prior line of platinum-based doublet chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK/KRAS) are required to have progressed on targeted therapy in addition to a platinum-based doublet chemotherapy
- •Phase 1a dose escalation and Phase 1b Cohort 3: Participants with RCC whose disease has progressed after 1 prior line of antiangiogenic therapy and a PD-1-axis inhibitor.
- •Medically suitable for surgical resection of tumor tissue
- •Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate bone marrow and organ function
排除标准
- •History of another primary malignancy within the previous 3 years
- •Phase 1a:
- •EOC of the following subtypes: low-grade, endometrioid, clear cell, mucinous, sarcomatous, or mixed.
- •NSCLC of the following subtypes: squamous, neuroendocrine differentiation.
- •RCC of the following subtypes: nonclear-cell RCC
- •Phase 1b:
- •Cohort 1: Participants with mucinous, sarcomatous, and low-grade EOC.
- •Cohort 2: Participants with small cell lung cancer, or NSCLC with neuroendocrine differentiation
- •Cohort 3: Participants with nonclear-cell RCC, except papillary RCC
- •Previously received an allogeneic stem cell transplant or organ allograft
- •Previously received TIL or engineered cell therapy (eg, CAR T-cell)
- •Significant cardiac disease
- •Stroke or transient ischemic attack within 12 months of enrollment
- •History of significant central nervous system (CNS) disorder
- •Symptomatic and/or untreated CNS metastases
- •History of significant autoimmune disease within 2 years prior to enrollment
- •Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), human serum albumin (HAS), phosphate buffer or gentamycin
研究组 & 干预措施
Phase 1b: Expansion
Experimental
Cohort 1: Participants with epithelial ovarian cancer (EOC)
Cohort 2: Participants with non-small cell lung cancer (NSCLC)
Cohort 3: Participants with renal cell carcinoma (RCC)
干预措施: ITIL-306 (Biological)
Phase 1a: Dose Escalation
Experimental
Various doses will be tested in participants with EOC, NSCLC and RCC.
干预措施: ITIL-306 (Biological)
结局指标
主要结局
Frequency and severity of ITIL-306 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (AESI)
时间窗: Up to 24 months
次要结局
- Progression-free survival (PFS)(Up to 60 months)
- Objective response rate (ORR)(Up to 60 months)
- Duration of response (DOR)(Up to 60 months)
- Overall Survival (OS)(Up to 60 months)
研究者
研究点 (2)
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