NCT03517488已完成1 期
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xencor, Inc.
- 入组人数
- 150
- 试验地点
- 32
- 主要终点
- Determine the safety and tolerability profile of XmAb20717
研究概览
简要总结
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors:
- •PART A (Dose Escalation Cohorts)
- •Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);
- •Hepatocellular carcinoma;
- •Urothelial carcinoma;
- •Squamous cell carcinoma of the head and neck;
- •Renal cell carcinoma (clear cell predominant type);
- •Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
- •Non-small cell lung carcinoma;
- •Gastric or gastroesophageal junction adenocarcinoma
- •Mesothelioma;
- •High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
- •Cervical cancer;
- •Squamous cell carcinoma of the anus
- •PART B (Dose Expansion Cohorts):
- •Renal cell carcinoma (clear cell predominant type)
- •Non-small cell lung carcinoma
- •Castrate-resistant adenocarcinoma of the prostate, defined as progressive disease after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (< 50 ng/dL)
- •Nasopharyngeal carcinoma
- •Cholangiocarcinoma
- •Basal cell carcinoma
- •Squamous cell carcinoma of the anus
- •Mesothelioma
- •Ovarian or fallopian tube carcinoma
- •Malignant adnexal neoplasms (including, but not limited to, sebaceous carcinoma, trichilemmal carcinoma, pilomatrix carcinoma, eccrine carcinoma, hidradenocarcinoma, adnexal carcinoma with divergent differentiation, papillary digital eccrine adenocarcinoma, microcystic adnexal carcinoma, and clear cell eccrine carcinoma)
- •Thymic carcinoma
- •Squamous cell carcinoma of the penis
- •Neuroendocrine carcinoma
- •Vulvar cancer
- •Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma)
- •Subjects with other solid tumors for which there is published evidence of anti-tumor activity with anti-PD1/PDL1 and/or anti-CTLA4-directed therapy but for which there is no FDA-approved anti-PD1/PDL1 or CTLA4-directed checkpoint inhibitor treatment may be eligible for Part B after approval by the Medical Monitor.
- •All subjects' cancer must have progressed after treatment with all standard therapies or have no appropriate available therapies.
- •Subjects, except those with adenocarcinoma of the prostate, must have measurable disease by RECIST 1.
- •Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
- •ECOG performance status of 0 - 1
- •Subjects with adenocarcinoma of the prostate must have evaluable disease (measurable or nonmeasurable lesions) by PCWG3.
排除标准
- •Subjects currently receiving other anticancer therapies, with the exception of subjects with adenocarcinoma of the prostate, who may continue luteinizing hormone-releasing hormone (LHRH) analogue therapy.
- •Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
- •Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the start of study drug.
- •Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort dependent).
- •Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.). Subjects with prostate cancer may continue LHRH analogue therapy.
- •A life-threatening (Grade 4) immune-mediated AE related to prior immunotherapy.
- •Failure to recover from any immune-related toxicity from prior cancer therapy to ≤ Grade 1, except if previous immune-related endocrinopathy is medically managed with hormone replacement therapy only.
- •Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade
- •Have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging, are clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- •Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs).
- •Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted).
- •Receipt of an organ allograft.
- •Prior treatment with any checkpoint inhibitor therapy regimen that targets both PD1/L1 and CTLA-4.
结局指标
主要结局
Determine the safety and tolerability profile of XmAb20717
时间窗: 56 Days
Treatment-related adverse events as assessed by CTCAE v4.03
次要结局
未报告次要终点
研究者
研究点 (32)
Loading locations...
相似试验
已完成
1 期
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)Melanoma (Excluding Uveal Melanoma)Cervical CarcinomaPancreatic CarcinomaBreast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 NegativeUrothelial CarcinomaSquamous Cell Carcinoma of the Head and NeckColorectal CarcinomaEndometrial CarcinomaNon-small Cell Lung CarcinomaHepatocellular CarcinomaGastric or Gastroesophageal Junction AdenocarcinomaAdvanced Solid TumorsUndifferentiated Pleomorphic SarcomaRenal Cell CarcinomaNasopharyngeal CarcinomaSmall Cell Lung CancerNCT03752398Xencor, Inc.198
已完成
1 期
A Study of XmAb®18087 in Subjects With NET and GISTGastrointestinal NeoplasmNeuroendocrine TumorNCT03411915Xencor, Inc.62
已完成
1 期
A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid TumorsCervical CarcinomaPancreatic CarcinomaTriple Negative Breast CancerUrothelial CarcinomaSquamous Cell Carcinoma of the Head and NeckHepatocellular CarcinomaMelanomaRenal Cell CarcinomaNon-small Cell Lung CarcinomaSmall Cell Lung CarcinomaGastric or Gastroesophageal Junction AdenocarcinomaAdvanced or Metastatic Solid TumorsProstate CarcinomaFallopian Tube CancerPrimary Peritoneal CarcinomaSquamous Cell Anal CancerSquamous Cell Penile CarcinomaSquamous Cell Vulvar CarcinomaColorectal CarcinomaEndometrial CarcinomaIntrahepatic CholangiocarcinomaEpithelial Ovarian CancerNasopharyngeal CarcinomaNCT03849469Xencor, Inc.78
已完成
1 期
Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)RicinNCT01317667U.S. Army Medical Research and Development Command30
已完成
1 期
A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant CancerAdvanced Malignant NeoplasmNCT06344351Chia Tai Tianqing Pharmaceutical Group Co., Ltd.27