CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events.
研究概览
简要总结
A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer
- •FIGO Stage III or IV
- •Positive for claudin 6 (CLDN6) expression
- •Adequate organ function
排除标准
- •Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers
- •Prior systemic treatment for the disease under study
- •Prior surgery
- •Prior radiation therapy to the abdomen or pelvis
- •Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic/targeted therapy, herbal medications or supplements, immunomodulator therapy for any disease indication.
- •History of noninfectious pneumonitis/interstitial lung disease (ILD) within 6 months of first dose of study drug.
- •Active, progressive, or symptomatic brain metastases
- •Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases
- •Pregnant or breastfeeding women
研究组 & 干预措施
Treatment Arm B: TORL-1-23 and carboplatin
Administered once every three weeks
干预措施: TORL-1-23 and carboplatin (Combination Product)
Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin
Administered once every three weeks
干预措施: TORL-1-23, paclitaxel, and carboplatin (Combination Product)
Treatment Arm A: TORL-1-23 and paclitaxel
Administered once every three weeks
干预措施: TORL-1-23 and paclitaxel (Combination Product)
结局指标
主要结局
Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events.
时间窗: Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE)
To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy
时间窗: postoperative after Cycle 4 (Each cycle is 21 days)
Determination of percentage CRS3 score for each treatment arm
次要结局
- To assess the tolerability of TORL-1-23 in combination with chemotherapy(Treatment up to Cycle 8 (each cycle is 21 days))
- To characterize duration of benefit for TORL-1-23 plus chemotherapy(Measured up to 15 months after surgery)