A Phase 2, Multicenter, Randomized, Open-label Study of DS-7300a, a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Inoguchi Akihiro0 个研究点目标入组 80 人开始时间: 2022年5月19日最近更新: 2024年5月27日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 80

研究概览入排标准研究者记录与标识符相似试验

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: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•1. Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
•2. Participant must have at least one lesion, not previously irradiated, amenable to core biopsy.
•3. Male or female subjects aged >=18 years
•4. Histologically or cytologically documented ES-SCLC.
•5. At least one measurable lesion according to RECIST v1.1 as assessed by the investigator.
•6. Prior therapy with at least one platinum-based line as systemic therapy for extensive-stage disease with at least two cycles of therapy (except in the case of early objective PD).
•7. Documentation of radiological disease progression on or after most recent systemic therapy.
•8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

排除标准

•1. Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents.
•2. Prior treatment with an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan).
•3. Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
•4. Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or arterial thromboembolic event.
•5. Clinically significant corneal disease.
•6. Uncontrolled or significant cardiovascular disease.
•7. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
•8. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
•9. Chronic steroid treatment (maximum dose of 10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions) or intra-articular steroid injections.
•10. History of malignancy other than SCLC within the 3 years prior to enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal (GI) tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
•11. History of allogeneic bone marrow, stem cell, or solid organ transplant.
•12. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0), Grade <=1 or baseline.
•13. History of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
•14. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection).
•15. Active or uncontrolled hepatitis B or C infection.
•16. Active, known, or suspected autoimmune disease.
•17. Any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness/social situations, substance abuse).
•18. Has received a live vaccine within 30 days prior to the first dose of study drug.
•19. Female who is pregnant or breast-feeding or intends to become pregnant during the study.
•20. Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant.

研究者

发起方

Inoguchi Akihiro

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