NCT04186637终止1 期
An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 10
- 主要终点
- Adverse Events
研究概览
简要总结
This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 to 75 years old at screening
- •Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology
- •Part A (Dose Escalation)
- •that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved
- •or for which standard or curative therapy is not available
- •Part B (Dose Expansion)
- •metastatic cutaneous melanoma
- •PD-L1-positive cancers (other than cutaneous melanoma or renal cell carcinoma)
- •metastatic renal cell carcinoma
- •Protocol-defined measurable disease
- •Available tumor biopsy representative of current disease
- •ECOG performance status grade 0-2
- •Life expectancy of ≥ 3 months
- •Recovery to ≤ Grade 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to first dose of ALPN-202 (except alopecia, hearing loss, ≤ Grade 2 neuropathy or endocrinopathy managed with replacement therapy)
- •Adequate baseline hematologic, renal, and hepatic function
排除标准
- •History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
- •Active or prior pneumonitis or interstitial lung disease
- •Presence of any active central nervous system metastases
- •Prior organ allograft or allogeneic hematopoietic stem cell transplantation
- •Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
- •Receipt of any protocol-restricted therapy within the timeframes indicated:
- •PD-L1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days)
- •Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks
- •Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks
- •Any active, known, or suspected autoimmune disease
- •Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication
- •Any second malignancy active within the previous 3 years
- •Active infection requiring therapy at the time of the first dose of ALPN-
- •Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C.
- •Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.
- •History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.
研究组 & 干预措施
Dose escalation and expansion
Experimental
ALPN-202
干预措施: ALPN-202 (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 30 days after last dose of study drug
Type, incidence, and severity of adverse events as assessed by CTCAE
次要结局
- Objective response(Up to 30 days after last dose of study drug)
研究者
研究点 (10)
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