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积极招募
DB-1311在晚期/转移性实体瘤中的研究
关于
简短的总结
This is a dose-escalation and dose-expansion 阶段 1/2a trial to evaluate the safety and tolerability of DB-1311 in subjects with advanced solid tumors.
主要目的
研究类型
阶段
资格
性别
健康的志愿者
最低年龄
最高年龄
入选标准:
- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; or for which no standard treatment is available.
- At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1标准. Castrate-resistant prostate cancer (CRPC) participants with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.
- 预期寿命≥3个月.
- 东部肿瘤合作组织(ECOG)绩效状态(PS)是否为0-1.
- Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
- Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of B7-H3 level and other biomarkers if no contraindication. 注意:没有最低B7-H3表达水平要求进入研究.
- Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.
- Male and female subjects of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, 分别.
- 从筛查开始到整个研究期间，男性受试者不得冷冻或捐献精子, 并且在最终研究用药后至少4个月.
- 女性受试者不得捐赠, 或为自己的使用检索, 卵子从筛查开始到整个研究治疗期间, 并且在最后的研究用药后至少持续7个月.
- SCLC参与者(仅限2a期队列1):
- 病理证明局部进展, 或转移性SCLC不适合手术或放疗治疗.
- Relapsed/progressed on or after 2 cycles of platinum-based chemotherapy in combination with/without anti-PD-1/anti-PD-L1 monoclonal antibody or intolerant to completion of 2 cycles of platinum-based chemotherapy due to the toxicity for locally advanced or metastatic disease.
- NSCLC参与者(仅限2a期队列2):
- 病理证明局部进展, 或转移性非小细胞肺癌，不适合手术或放疗治疗.
- Has received prior treatment with platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 antibody-based regimen in the advanced/unresectable, 除非不能或不愿意. 已知非小细胞肺癌患者除EGFR突变外，还存在基因组改变(如EGFR突变).g., 碱性重排, ROS1重排, KRAS G12C突变, BRAF V600E突变, NTRK1/2/3基因融合, MET外显子14跳过, RET重组等.) for which treatment is available must have also received prior treatment with at least 1 genotype-directed therapy.
- ESCC参与者(仅限2a期队列3):
- 病理证明局部进展, 或转移性ESCC，不适合治疗性手术或放疗.
- 既往接受过至少一种不可切除疾病的治疗. Patients with recurrence within 6 months of completion of neoadjuvant or adjuvant therapy will be considered as having received one prior therapy for unresectable disease.
- CRPC参与者(仅限2a期队列4):
- 病理证实的前列腺癌转移性腺癌.
- Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone < 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.
- 既往接受过多西他赛(在ar靶向治疗之前或之后). 允许多西他赛重新挑战.
- 曾接受过新型激素治疗的.
- 黑色素瘤参与者(仅限2a期队列5)
- Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy, 肯定有:
- 既往使用PD-1或PD-L1抑制剂治疗.
- 如果参与者携带BRAF基因突变的黑色素瘤, 之前一定接受过包括vemurafenib在内的治疗方案, dabrafenib, 或其他BRAF基因和/或丝裂原活化蛋白激酶(MEK)蛋白抑制剂.
- 其他实体肿瘤患者(仅限2a期队列6)
- 组织学或细胞学证实为实体瘤.
- Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving DB-1311 are available prior to consenting to participate in this trial).
排除标准:
除另有指明外，排除准则适用于第1期及第2a期. 符合以下任何条件的受试者将被排除在研究之外:
- 既往接受B7-H3靶向治疗.
- 先前使用抗体药物结合拓扑异构酶抑制剂(e.g.(曲妥珠单抗德鲁西替康).
- Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
- 入组前6个月内有心肌梗死或不稳定型心绞痛病史.
- Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
- 不能或不愿意停用已知可延长QT间期的合用药物.
- 有肺间质性疾病的病史(如.g., 非感染性间质性肺炎, 肺炎, 肺纤维化, and severe radiation 肺炎) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
- 是否有潜在的肺部疾病史，包括, 但不限于, 研究治疗开始后3个月内出现肺栓塞, 严重的哮喘, 严重的慢性阻塞性肺病, 限制性肺病, 以及其他有临床意义的肺损伤或需要补充氧气.
- 任何自身免疫性、结缔组织或炎症性疾病(如.g., 类风湿性关节炎, 干燥的, 结节病), 或在筛查时怀疑肺部受累.
- 是否有无法控制的感染需要静脉注射抗生素, 抗病毒药物, 或抗真菌.
- 了解人类免疫缺陷病毒(HIV)感染.
- 排除有活动性病毒性肝炎(任何病因)的受试者. 然而, subjects with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen [HBsAg] test or a positive hepatitis B core antibody test) who have a viral load below the limit quantification (HBV DNA titer < 1000 cps/mL or 200 IU/mL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor. 然而, subjects with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry.
- 是哺乳期的母亲(愿意暂时中断母乳喂养的妇女也将被排除在外), 或在入组前7天内通过妊娠试验确认怀孕.
- 脊髓压迫或临床活跃的中枢神经系统是否有转移, 定义为未经治疗和有症状, 或者需要使用皮质类固醇或抗惊厥药物来控制相关症状. 临床不活跃的脑转移患者也可纳入研究. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. 在全脑放疗结束和研究随机化之间必须至少经过2周.
- 以前的抗癌治疗是否有未解决的毒性, 定义为NCI-CTCAE第5版尚未解决的毒性(脱发除外).0，等级≤1或基线. 慢性2级毒性受试者(如.g., 2级神经病)可能符合条件，基于研究者和申办者之间的讨论和协议.
- 入组前3年内是否有多发原发性恶性肿瘤, 除非充分切除非黑色素瘤皮肤癌(如.g.，切除基底细胞或鳞状细胞皮肤癌)，治愈原位疾病(如.g.(如宫颈原位癌或乳腺原位癌)，其他已治愈的实体瘤(如.g.(浅表性膀胱癌)或对侧乳腺癌.
- Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.
- 已知对原料药或药品中的非活性成分过敏.
- 患者有其他原因, 根据调查员的意见, 使他们不适合参与这项研究.
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研究统计数据
协议没有.
23-001699
类别
结肠直肠癌
食道癌
肾癌
肝癌
肺癌
黑色素瘤(皮肤癌)
其他癌症
前列腺癌
联系
位置
- 皇冠hga025大学圣莫尼卡分校