NCT04541225终止1 期
Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
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
- 74
- 试验地点
- 12
- 主要终点
- Phase 1 Dose Escalation: Safety and tolerability of NUV-422 to determine the recommended Phase 2 dose (RP2D)
研究概览
简要总结
At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422. The study population comprised adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and without brain metastases, and recurrent or refractory metastatic castration-resistant prostate cancer (mCRPC). All patients self-administered NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
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
- •In addition to the inclusion criteria listed above, the following criteria apply based on enrollment into specific cohorts.
- •High-Grade Glioma:
- •Histologically confirmed diagnosis of high-grade glioma
- •Evidence of recurrence after treatment (ie, surgery, radiation, or temozolomide) or refractory (or intolerant) to treatment
- •Measurable or non-measurable disease
- •Karnofsky Performance Status (KPS) score ≥ 60
- •HR+HER2- Metastatic Breast Cancer:
- •Men and women who are not suitable for surgical resection or radiotherapy for the purpose of cure
- •Diagnosis of locally advanced or HR+HER2- metastatic breast cancer
- •Evidence of progression as determined by the Investigator per standard criteria
- •Patients must have endocrine-resistant disease
- •Prior therapy: At least 1 but not more than 4 prior lines of systemic therapies for locally advanced inoperable or metastatic BC including at least 1 prior line of hormonal therapy in combination with an approved CDK4/6 inhibitor
- •Have no known active or symptomatic central nervous system (CNS) disease
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- •Metastatic Castration-Resistant Prostate Cancer:
- •Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
- •Evidence of disease progression as determined by Investigator per standard criteria
- •Have no known active or symptomatic CNS disease
- •Received prior therapy with anti-androgen(s) and taxane-based chemotherapy for castration-resistant disease
- •ECOG PS ≤ 2
- •Key Exclusion Criteria for All Cohorts:
- •Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422
- •Has a history of or current use of bevacizumab (glioma and brain metastases only)
- •Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or < 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422
- •Requires systemic corticosteroid therapy > 4 mg/day (> 2 mg/day for Expansion Cohort 2) of dexamethasone or equivalent or increasing doses of systemic corticosteroids during the 7 days prior to enrollment
- •Requires anti-seizure medications that are known to be strong inducers of CYP3A4/5 enzymes (carbamazepine, phenytoin) or has a recent history of uncontrolled or intermittent seizures
- •Females who are pregnant or breast feeding
排除标准
- 未提供
研究组 & 干预措施
Phase 1 Dose Escalation
Experimental
NUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
干预措施: NUV-422 (Drug)
结局指标
主要结局
Phase 1 Dose Escalation: Safety and tolerability of NUV-422 to determine the recommended Phase 2 dose (RP2D)
时间窗: During the DLT period (28 days)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
相似试验
撤回
1 期
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPCProstatic CancerCancer of ProstateCancer of the ProstateProstate NeoplasmCastrate Resistant Prostate CancerCastration Resistant Prostatic CancerCastration Resistant Prostatic NeoplasmsProstate CancerNCT05191017Nuvation Bio Inc.
招募中
1 期
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)Chronic Lymphocytic LeukemiaMantle Cell LymphomaMixed Phenotype Acute LeukemiaFollicular LymphomaNCT06533579Vironexis Biotherapeutics Inc.32
招募中
1 期
Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid TumorsSolid Tumor, Unspecified, AdultNCT04643418MegaPro Biomedical Co. Ltd.81
招募中
1 期
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-DegraderB-cell MalignancyNon-Hodgkin LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMarginal Zone LymphomaDLBCL UnclassifiableRichter's TransformationMantle Cell LymphomaFollicular LymphomaWaldenström MacroglobulinemiaNCT05294731BeiGene146
已完成
1 期
Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)OncologyNon Small Cell Lung CancerEGJEsophagogastric Junction CancerHead and Neck CancerBreast CancerCancerColorectal CancerOvarian CancerPancreatic CancerGastric CancerMelanomaColon CancerCRCUrothelial CancerBladder CancerNSCLCNCT05259696Palleon Pharmaceuticals, Inc.69