NCT05429762终止1 期
Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic 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
- 发起方
- Sanofi
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- Change from baseline in QT-interval corrected (QTcF) centrally assessed
研究概览
简要总结
This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.
详细描述
This is a single arm study in which participants will receive treatment with tusamitamab ravtansine until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC) adenocarcinoma, nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GC/GEJ) adenocarcinoma, metastatic disease at study entry.
- •Participants with documented disease progression, for which, in the judgment of the Investigator, no alternative medical therapy is available.
- •Expression of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) will be assessed centrally using the most recent archival tumor tissue (or, if not available, a fresh biopsy sample) and at least 5 fresh-cut slides of formalin-fixed paraffin embedded (FFPE) tumor tissue sectioned. If less material is available, the participant could still be considered eligible after discussion with the Sponsor.
- •Participants with CRC tumors may be assumed to have adequate CEACAM5 expression without testing results (it will be assessed retrospectively),
- •Participants with NSQ NSCLC must have tumors expressing CEACAM5 or high circulating CEA if tumor tissue is not available.
- •Participants with GC/GEJ must have tumors expressing CEACAM5
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as determined by the Investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) and is a WOCBP and agrees to use a contraceptive method that is highly effective and for at least 7 months after the last dose of treatment. administration.
- •Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration.
- •Capable of giving signed informed consent.
排除标准
- •Untreated brain metastases that may be considered active or leptomeningeal metastasis. A participant with asymptomatic brain metastasis/metastases is eligible.
- •Significant concomitant illness
- •History within the last 2 years of an invasive malignancy other than that treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- •Any major surgery within 3 weeks prior to of first study intervention administration.
- •Known uncontrolled infection with human immunodeficiency virus (HIV). Participants with a well-controlled HIV infection/disease must be on antiretroviral therapy (ART) to be eligible.
- •Active infection with hepatitis A, B, or C.
- •Nonresolution of any prior treatment-related toxicity .
- •Unresolved corneal disorder or any previous corneal disorder.
- •Use of contact lenses is not permitted.
- •Prior history of Torsades de Pointes, or congenital long QT syndrome.
- •Patient receives (and cannot discontinue) or is scheduled to receive a QT-prolonging drug unless if deemed necessary for the participant as per the investigators' judgment and started at least 4 weeks prior IMP administration at the same dose and the same frequency.
- •QTcF interval >480 msec on screening ECG.
- •Poor bone marrow, liver, kidney functions, or electrolytes values
- •Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- •The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
研究组 & 干预措施
Tusamitamab ravtansine
Experimental
Participants will receive tusamitamab ravtansine intravenous (IV) infusion until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.
干预措施: Tusamitamab ravtansine (Drug)
结局指标
主要结局
Change from baseline in QT-interval corrected (QTcF) centrally assessed
时间窗: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
次要结局
- ECG parameter: QT interval(Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks))
- ECG parameter: QRS interval(Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks))
- Electrocardiogram (ECG) parameter: heart rate (HR)(Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks))
- ECG parameter: QT interval corrected according to the Bazett's formula (QTcB)(Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks))
- ECG parameter: PR interval(Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks))
- Maximum concentration observed (Cmax)(Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks))
- Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d)(Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks))
- Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities(From the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks)
- Overall response rate (ORR)(Up to approximately 30 weeks)
- Duration of response (DOR)(Up to approximately 30 weeks)
研究者
研究点 (7)
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