A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 143
- 主要终点
- Objective Response by IRC
研究概览
简要总结
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- •Have platinum-resistant disease:
- •Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.
- •Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
- •Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years.
- •Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.
- •Must have received bevacizumab unless there was a contraindication for its use.
- •If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.
排除标准
- •Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
- •Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
- •The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
- •Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
- •Known active CNS metastases and/or carcinomatous meningitis.
- •Known additional malignancy that is progressing or requires active treatment.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Cohort 3
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
干预措施: INCB123667 (Drug)
Cohort 1
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
干预措施: INCB123667 (Drug)
Cohort 2
INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.
干预措施: INCB123667 (Drug)
结局指标
主要结局
Objective Response by IRC
时间窗: Up to 2 years
Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
次要结局
- Duration of Response (DOR) by IRC(Up to 2 years)
- Progression-Free Survival (PFS) by IRC(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Objective Response by Investigator(Up to 2 years)
- DOR by investigator(Up to 2 years)
- PFS by Investigator(Up to 2 years)
- Treatment Emergent Adverse Events (TEAE'S)(Up to 2 years and 30 days)
- TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment(Up to 2 years and 30 days)