NCT04920383终止1 期
An Open-label Study of ALPN-202 Combined With PD-1 Inhibition in Subjects With Advanced Malignancies (NEON-2)
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
- 29
- 试验地点
- 5
- 主要终点
- Dose-limiting Toxicities (DLTs)
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.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 to 80 years old at screening
- •Pathologically confirmed, locally advanced or metastatic unresectable solid tumor, or Hodgkin or Non-Hodgkin lymphoma (including transformed lymphoma) of an acceptable histology:
- •that is eligible for treatment with a PD-1 or PD-L1 inhibitor, or
- •that is refractory or resistant to standard therapy, or
- •for which standard or curative therapy is not available.
- •Have received ≥ 2 prior systemic anti-cancer therapies (lymphoma subjects only)
- •Protocol-defined measurable disease
- •Available tumor biopsy representative of current disease
- •ECOG performance status grade 0-1
- •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, hepatic and cardiac function
排除标准
- •Any history of ≥ Grade 3 immune-related adverse event (irAE) requiring discontinuation from treatment or any history of a cardiovascular irAE
- •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 other 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:
- •Checkpoint inhibitors, including PD-(L)1 (e.g., pembrolizumab, nivolumab, cemiplimab, avelumab, durvalumab), CTLA-4 (e.g., ipilimumab, tremelimumab), and Lag-3 (e.g., relatlimab), costimulatory agonists (including but not limited to CD28, CD134 (OX40), CD137 (4-1BB)): 3 months (135 days for atezolizumab)
- •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, or or Severe Acute Respiratory Syndrome Coronavirus
- •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.
- •Any serious or uncontrolled cardiovascular condition, including but not limited to:
- •Any history of myocarditis of any etiology
- •History of New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, cerebrovascular accident, cardiac hospitalization, or other acute uncontrolled heart disease within 6 months of scheduled C1D1
- •Left ventricular ejection fraction < 45% on screening echocardiogram
- •Any clinically significant findings on screening EKG such as atrial or ventricular arrythmia (other than sinus tachycardia) or AV conduction abnormality such as left bundle branch block (such subjects may be enrolled after cardiology clearance and Medical Monitor approval)
- •Has received prior radiotherapy within 2 weeks of start of study treatment, or have had a history of radiation pneumonitis
研究组 & 干预措施
Dose Escalation and Expansion
Experimental
ALPN-202 + pembrolizumab KEYTRUDA®
干预措施: pembrolizumab KEYTRUDA® (Drug)
Dose Escalation and Expansion
Experimental
ALPN-202 + pembrolizumab KEYTRUDA®
干预措施: ALPN-202 (Drug)
结局指标
主要结局
Dose-limiting Toxicities (DLTs)
时间窗: Up to 6 weeks following study day 1
Incidence of DLTs
Laboratory Abnormalities
时间窗: Up to 30 days after last dose of study drug
Type, incidence, and severity of laboratory abnormalities
Adverse Events (AEs)
时间窗: 30 days after last dose of study drug
Type, incidence, severity, and seriousness of AEs
次要结局
未报告次要终点
研究者
研究点 (5)
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