2023-504111-33-00招募中2 期
A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, vs Investigator's Choice Chemotherapy in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 17
- 主要终点
- 2. Occurence of TRAEs leading to discontinuation.
研究概览
简要总结
- To compare objective response rate of MORAb-202 vs Investigator's Choice (IC) chemotherapy (in all randomized participants)
- To evaluate the proportion of participants with treatment-related adverse events (TRAEs) leading to discontinuation in each arm within 6 months from first dose of study drug administration in all treated participants
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be 18 years old or local age of majority at the time of signing the informed consent
- •Female participants with histologically confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
- •Platinum-resistant disease, defined as: - For participants who had only 1 line of platinum-based therapy: progression between > 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles. - For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy.
- •Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance. - Participants must have received prior treatment with bevacizumab or must be deemed medically inappropriate or ineligible/intolerant to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.NOTES: Neoadjuvant ± adjuvant chemotherapy will be considered 1 line of therapy. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy. Therapy changed in the absence of progression will be considered part of the same line.
- •Disease progression per RECIST v1.1 (by Investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
- •Either formalin-fixed, paraffin-embedded (FFPE) tissue or newly obtained biopsies must be available for FRα assessment prior to randomization.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
排除标准
- •Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer
- •Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- •Inadequate liver function evidenced by abnormal levels of total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or serum albumin
- •Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients
- •History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C
- •Participants currently in other interventional trials may not participate in BMS clinical trials until the protocol specific washout period is achieved
- •Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
- •Clinically significant pericardial effusion requiring drainage
- •Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before treatment.
- •Recent chest radiotherapy received under 6 months before starting study treatment
- •Any autoimmune, connective tissue, or inflammatory disorders where there is documented (or suspicion of) pulmonary involvement
- •Uncontrolled or significant cardiovascular conditions within 6 months prior
- •Uncontrolled medical disorders that, in the opinion of the Investigator or Sponsor, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results
- •Prior treatment with an investigational FRα-targeting agent and FRα-targeting ADC
研究组 & 干预措施
farletuzumab ecteribulin
Experimental
Participants receiving farletuzumab ecteribulin
干预措施: farletuzumab ecteribulin (Drug)
结局指标
主要结局
2. Occurence of TRAEs leading to discontinuation.
2. Occurence of TRAEs leading to discontinuation.
1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment
1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment
次要结局
- 1. Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs, deaths and laboratory abnormalities
- 2. DoR by RECIST v1.1 per investigator Assessment among responders
- 3. PFS by RECIST v1.1 per Investigator Assessment
研究者
GSM-CT Representative
Scientific
Bristol Myers Squibb International Corporation
研究点 (17)
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