CTRI/2026/01/100358尚未招募1/2 期
A Phase 1/2, Multicenter, Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of sacituzumab vedotin alone and in combination with anti- PD-1/PD-L1 monoclonal antibody in Patients with Advanced Epithelial Tumors
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 11
研究概览
简要总结
This is a First-in-Human, Phase 1/2 study of sacituzumab vedotin aimed at characterizing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy in adult patients with advanced or metastatic epithelial tumors. The study has been designed with a stepwise approach Phase 1a (dose escalation) will determine the recommended dose range (RDR) of sacituzumab vedotin, both as monotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and/or female patients aged greater than equal to 18 years at the time of giving the informed consent.
- •2.Ability to understand, agree to, and voluntarily give a written informed consent form prior to initiation of any study specific procedures.
- •In case of illiterate participants, thumb impression of the participants will be obtained along with the signature of the impartial witness on the consent form prior to participants participation in the trial.
- •Histologically or cytologically confirmed unresectable, locally advanced, or metastatic epithelial malignancy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening.
- •5.Estimated life expectancy of greater than equal to 3 months as assessed by the Investigator.
- •6.Willingness and ability, as assessed by the Investigator, to comply with All protocol required procedures, Scheduled visits, Treatment administration, Laboratory evaluations, Imaging assessments, Follow-up requirements.
- •7.Individuals who are otherwise medically stable based on physical examination, medical history, vital signs, 12 lead ECG, and clinical laboratory tests performed at screening.
- •Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.
- •Phase 1a Dose Escalation 1.Patients must have histologically or cytologically confirmed advanced or metastatic epithelial malignancy that is not amenable to curative treatment.
- •2.Preferably at least one measurable lesion as defined by RECIST version 1.1, confirmed by radiologic imaging within 28 days prior to enrolment.
排除标准
- •1.Known hypersensitivity or allergic reactions to monoclonal antibodies, MMAE, or any component of the investigational product formulation.
- •2.History of or active interstitial lung disease (ILD), drug-induced pneumonitis, or pulmonary fibrosis requiring systemic corticosteroids, clinically significant COPD, or other moderate-to-severe chronic respiratory illness.
- •3.Known history of organ transplantation (solid organ or allogeneic stem cell).
- •4.Receipt of live or live-attenuated vaccines within 28 days prior to the first dose of study drug, or planned during the study.
- •5.Documented medical history of a poorly controlled/clinically significant medical condition or laboratory parameters or other relevant medical disease, such as a neurological, psychiatric, pulmonary, gastrointestinal, or endocrine disease or a history of clinically significant hematological, renal, or liver disease or any other condition that, in the opinion of the investigator, would put the patient at risk by participation in the trial or deemed by the clinician to be likely to interfere with a participant’s compliance and ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
研究者
Dr Deven V Parmar MD FCP
Zydus Lifesciences Limited
研究点 (11)
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