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Abstract：
This phase 1 study investigated safety/tolerability, pharmacokinetics, and preliminary efficacy of SC-002, a delta-like ligand 3-directed antibody-drug conjugate, in advanced small cell lung cancer and large cell neuroendocrine carcinoma.
Eligible patients received SC-002 at 1 of 7 dose levels during the dose-escalation portion of the study.
Thirty-five enrolled patients received ≥1 dose of SC-002. Twenty-three (66%) patients experienced serious adverse events (AEs), 37% considered related to SC-002. Grade 3/4 AEs occurred in 21 (60%) and 2 (6%) patients; the most common were effusion and hypoalbuminemia. One grade 5 AE occurred in 1 patient. Five (14%) patients achieved a partial response and no patients achieved a complete response.
SC-002 treatment was associated with systemic toxicity and limited efficacy.
Eligible patients received SC-002 at 1 of 7 dose levels during the dose-escalation portion of the study.
Thirty-five enrolled patients received ≥1 dose of SC-002. Twenty-three (66%) patients experienced serious adverse events (AEs), 37% considered related to SC-002. Grade 3/4 AEs occurred in 21 (60%) and 2 (6%) patients; the most common were effusion and hypoalbuminemia. One grade 5 AE occurred in 1 patient. Five (14%) patients achieved a partial response and no patients achieved a complete response.
SC-002 treatment was associated with systemic toxicity and limited efficacy.
摘要：
这项第一阶段研究调查了安全性/耐受性，药代动力学，SC-002，一种δ样配体3定向抗体-药物偶联物的初步功效，晚期小细胞肺癌和大细胞神经内分泌癌。
符合条件的患者在研究的剂量递增部分期间接受7个剂量水平中的1个的SC-002。
35名入选患者接受了≥1剂SC-002。23例（66%）患者出现严重不良事件（AE），37%被认为与SC-002有关。3/4级不良事件发生在21例（60%）和2例（6%）患者中；最常见的是积液和低蛋白血症。1例患者发生1例5级AE。五名（14％）患者获得了部分反应，没有患者获得了完全反应。
SC-002治疗与全身毒性和有限疗效相关。
符合条件的患者在研究的剂量递增部分期间接受7个剂量水平中的1个的SC-002。
35名入选患者接受了≥1剂SC-002。23例（66%）患者出现严重不良事件（AE），37%被认为与SC-002有关。3/4级不良事件发生在21例（60%）和2例（6%）患者中；最常见的是积液和低蛋白血症。1例患者发生1例5级AE。五名（14％）患者获得了部分反应，没有患者获得了完全反应。
SC-002治疗与全身毒性和有限疗效相关。
