NL-OMON54787招募中不适用
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300) - 20160323
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 10
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
- •Subject has provided informed consent prior to initiation of any study-specific
- •activities/procedures • Age > 18 years old at the time of signing the
- •informed consent • Histologically or cytologically confirmed SCLC: o Parts A,
- •C, D, E, F and Part G: RR SCLC who progressed or recurred following at least 1
- •platinum-based regimen; Note: Subjects with a diagnosis of combined small cell
- •carcinoma with predominant small cells (as determined by the local pathologist)
- •may be considered for inclusion in the dose escalation phase of part A based on
- •investigator discretion and after discussion with the medical monitor o Part B:
- •ED SCLC with ongoing clinical benefit (stable disease [SD], partial response
- •[PR], or complete response [CR]) following no more than 6 cycles of first-line
- •platinum-based chemotherapy with the last dose of chemotherapy greater then
- •equal to 28 days prior to the study day 1 (first-line consolidation setting).
- •Part B will not be opened. • Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0-2 • Minimum life expectancy of 12 weeks • RR SCLC only:
- •at least 2 measurable lesions as defined per modified RECIST 1.1 within 21 days
- •prior to the first dose of Tarlatamab. Subjects with 1 measurable lesion may be
- •considered for inclusion after discussion with the Medical Monitor. • Subjects
- •with treated brain metastases are eligible provided they meet the following
- •criteria: o Definitive therapy was completed at least 2 weeks prior to the
- •first dose of Tarlatamab. o There is no evidence of radiographic CNS
- •progression following definitive therapy and by the time of study screening.
- •Patients manifesting progression in lesions previously treated with
- •stereotactic radiosurgery may still be eligible if pseudo progression can be
- •demonstrated by appropriate means and after discussion with the medical
- •monitor. o Any CNS disease is asymptomatic for at least 7 days (unless symptoms
- •are deemed irreversible by the investigator), the patient is off steroids for
- •at least 7 days (physiologic doses of steroids are permitted), and the subject
- •is off or on stable doses of anti-epileptic drugs for malignant CNS disease for
- •at least 7 days. Please refer to section 4.1 of the protocol.
排除标准
- •History of other malignancy within the past 2 years prior to first dose of
- •Tarlatamab except: o Malignancy (other than in situ) treated with curative
- •intent and with no known active disease present for > 2 years before first
- •dose of Tarlatamab and felt to be at low risk for recurrence by the treating
- •physician. o Adequately treated non-melanoma skin cancer or lentigo maligna
- •without evidence of disease. o Adequately treated in situ cancer without
- •evidence of disease. o Prostatic intraepithelial neoplasia without evidence of
- •prostate cancer o Adequately treated urothelial papillary noninvasive carcinoma
- •Major surgery within 28 days of first dose Tarlatamab • Untreated (includes
- •new lesions or progression in previously treated lesions) or symptomatic brain
- •metastases and leptomeningeal disease • Myocardial infarction and/or
- •symptomatic congestive heart failure (New York Heart Association > class II)
- •within 12 months of first dose of Tarlatamab • History of arterial thrombosis
- •(eg, stroke or transient ischemic attack) within 12 months of first dose of
- •Tarlatamab • Subject with symptoms and/or clinical signs and/or radiographic
- •signs that indicate an acute and/or uncontrolled active systemic infection
- •within 7 days prior to the first dose of investigational product administration
- •Prior anti-cancer therapy: at least 28 days must have elapsed between any
- •prior anti-cancer therapy and first dose of Tarlatamab
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