NL-OMON53618招募中不适用
A Phase 1/2, open label, first-in-human, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SAR445877 administered as monotherapy in adults with advanced solid tumors - TCD17620
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •I 01. Participant must be at least 18 years of age inclusive, at the time of
- •signing the informed consent.
- •Dose escalation Part 1:
- •I 02. Participants with advanced unresectable or metastatic solid tumors for
- •which, in the judgement of the investigator, no standard alternative therapy is
- •available or is not in the best interest of the participant.
- •Dose expansion Part 2:
- •Cancer diagnosis:
- •I 03. Participants in Cohort A: Histologically or cytologically confirmed
- •diagnosis of metastatic NSCLC.
- •I 04. Participants in Cohort B: Histologically or cytologically confirmed
- •diagnosis of advanced unresectable or metastatic HCC, or clinically by American
- •Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic
- •patients (participants without cirrhosis must have had histological
- •confirmation of diagnosis).
- •I 05. Participants in Cohort C: Histologically or cytologically confirmed
- •diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ.
- •I 06. For participants in Cohort C: Disease with CPS scoring of <1 as
- •determined at local laboratory with an Agency approved test (for the other
- •cohorts: Disease with any CPS scoring. No need for CPS determination at local
- •laboratory).
- •I 07. For participants in Cohort C: Participants must have MSI or MMR status
- •known or determined locally and must have non-MSI-H or proficient MMR (pMMR)
- •disease to be eligible.
- •I 08. For participants in Cohort C: Participants with unknown HER2/neu status
- •must have their HER2/neu status determined locally. Participants with HER2/neu
- •negative are eligible.
- •Participants with HER2/neu positive tumors must have documentation of disease
- •progression on treatment containing an approved HER2 targeted therapy to be
- •Prior anticancer therapy (For dose expansion Part 2 only):
- •I 09. Participants in Cohort A: Participants must have received at least 1
- •systemic therapy for the metastatic setting and must not be amenable to the
- •available SOC.
- •Participants in Cohort B: Participants who have received at least 1 prior
- •anticancer therapy, including an anti-PD1/PD-L1 containing regimen, and for
- •whom have progressed
- •after a primary or secondary resistance to an anti-PD1/PD-L1.
- •Primary resistance: participant must have experienced PD or SD lasting <6
- •months since the initiation of the anti-PD1/PD-L1 inhibitor-based treatment and
- •the participant must have received PD1/PD-L1 for at least 6 weeks. Radiographic
- •confirmation of the PD must be documented after a minimum of 4 weeks after the
- •initial identification of progression, unless: 1) investigator confirms
- •clinical progression/deterioration attributed to PD, or 2) the first
- •radiographic assessment indicated critical tumor growth by imaging (size or
- •Secondary resistance: participants must have experienced PD, either during or
- •within 3 months of discontinuing treatment with an anti-PD1 based therapy,
- •occurring after previous clear benefit (any complete [CR] or partial response
- •[PR]), or after previous SD of >6 months. There is no requirement for
- •radiographic confirmation of the progression.
- •I 10. Participants in Cohort C: Participants should have failed or relapsed
- 另有 4 项未显示
排除标准
- •E 01. Eastern Cooperative Oncology Group (ECOG) performance status of >=2.
- •E 02. Predicted life expectancy <=3 months.
- •E 03. For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C
- •liver score. Participants with Child Pugh Class B-7 score are allowed for Part
- •E 04. Diagnosed of any other malignancies, either progressing or requiring
- •active treatments, within 2 years prior to enrollment, except for basal cell
- •carcinoma or squamous cell carcinoma of the skin, which are in-situ
- •malignancies, as well as superficial bladder carcinoma, or low risk prostate
- •cancer, and any tumors that have been deemed as effectively treated with
- •definitive local control.
- •E 05. Active brain metastases or leptomeningeal metastases:
- •Participants with previously treated brain metastases are eligible, provided
- •they are clinically stable for at least 4 weeks with no evidence of new or
- •enlarging brain metastases, and have not received corticosteroids for at least
- •2 weeks prior to the first IMP administration.
- •Participants with asymptomatic brain metastases (ie, no neurological
- •symptoms, no requirements for corticosteroids, and no lesion >1.5 cm) are
- •eligible but will require regular imaging of the brain at the site of the
- •E 06. History of treatment-related immune-mediated (or immune-related) AEs from
- •immune modulatory agents (including but not limited to anti-PD1/PD-L1 agents
- •and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies)
- •that caused permanent discontinuation of the agent, or that were Grade 4 in
- •severity, or have not resolved to Grade <=1.
- •E 07. Has any condition requiring ongoing/continuous corticosteroid therapy
- •(>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior
- •to the first dose of the study medicine. Physiologic replacement doses are
- •allowed even if they are >10 mg of prednisone/day or equivalent, as long as
- •they are not being administered for immunosuppressive intent. Inhaled or
- •topical steroids are permitted, provided that they are not for treatment of an
- •autoimmune disorder. Note: Participants who require a brief course of steroids
- •(up to 2 days in the week before enrollment) or physiologic replacement are
- •eligible to be enrolled in the study.
- •E 08. Any clinically significant cardiac (including valvular) or vascular
- •(thromboembolic disorders) disease, within 6 months prior to the first IMP
- •administration, such as:
- •Congestive heart failure (New York Heart Association Class II to IV, or left
- •ventricular ejection fraction <50%).
- •Increased troponin (higher than upper limit of normal [ULN] per local
- •laboratory) at screening. Participants with a higher troponin may be allowed
- •upon cardiologist consultation and discussion with the Study Medical Monitor on
- •a case-by-case basis.
- •Unstable or poorly controlled angina, myocardial infarction, coronary artery
- •revascularization procedure (eg, coronary artery bypass graft, percutaneous
- •coronary intervention).
- •Transient ischemic attack, cerebral infarction (stroke), symptomatic
- •pulmonary embolism, and peripheral artery revascularization procedure.
- •Uncontrolled cardiac arrhythmia requiring medication (>= Grade 2, according to
- •the NCI-CTCAE V5.0).
- •E 09. History of congenital long QT syndrome, torsades de pointes or prolonged
- •QTc interval >48
研究者
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