NCT05769660招募中1 期
An Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patient with Recurrent or Progressive Glioblastoma Multiforme (GBM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose(MTD)
研究概览
简要总结
This is a Phase 1 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
详细描述
In Phase 1, patients with recurrent or progressive glioblastoma multiforme who failed with the standard of care will be enrolled at each dose level of BEY1107 in combination with Temozolomide.
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
盲法说明
open label
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged over 19 years or older at the time of Informed Consent.
- •Diagnosed with GBM according to the World Health Organization(WHO) criteria.
- •Subjects with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
- •Subjects with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
- •Subjects with European Cooperative Oncology Group(ECOG) performance status 0 or
- •For Subjects using corticosteroids, those who do not need escalation within at least 2 weeks prior to administration of Investigational Product(IP) and on a stable dose.
- •Women of childbearing potential who are not surgically sterile must consent to practice acceptable contraception until 6 months after the end of IP administration and also have the evidence of not being fertile.
- •8 Non-vasectomized men who consent to use an acceptable contraception by one-self and the partner until 3 months after the end of IP administration.
- •Subjects who are fully informed of this trial, voluntarily decide to participate in the trial and provide written consent to comply with requirements for the trial.
排除标准
- •Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
- •Subjects who have not recovered from the toxicity of the prior anticancer therapy.
- •Subjects who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
- •Subjects who had a major surgery requiring general anesthesia within 4 weeks of screening.
- •Subjects with a history of other malignancy except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ, papillary thyroid cancer or early gastric cancer.
- •Subjects with a genetic problem(eg. Galactose intolerance).
- •Subjects with hypersensitivity to the ingredient(s) or excipient(s) of the investigational product (BEY1107) or temozolomide.
- •Subjects with hypersensitivity to dacarbazine (DTIC).
- •Subjects who have the cardiovascular disease as of screening.
- •Active hepatitis B, C or HIV positive.
- •Patients with acute or severe infection.
- •Subjects who take a Rifampin, Phenytoin and azole class antifungal drugs in combination.
- •Subjects who had been administered other IP within 4 weeks prior to screening.
- •Patients with inadequate bone marrow, kidney and liver function.
- •Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
- •Subjects with life expectancy of less than 12 weeks by the investigator.
- •Subjects determined by the investigator to be ineligible for participation in this trial.
研究组 & 干预措施
BEY1107 + Temozolomide
Experimental
Administer BEY1107 in combination with Temozolomide, 4-weeks as 1 cycle.
干预措施: BEY1107 (Drug)
BEY1107 + Temozolomide
Experimental
Administer BEY1107 in combination with Temozolomide, 4-weeks as 1 cycle.
干预措施: Temozolomide (Combination Product)
结局指标
主要结局
Maximum Tolerated Dose(MTD)
时间窗: From baseline up to disease progression, approximately 4 weeks
MTD will be assessed based on dose-limiting toxicity(DLT) assessment
Recommended Phase II Dose (RP2D) assessed by investigator following administration of BEY1107 in combination with Temozolomide in Phase I.
时间窗: From baseline up to disease progression, approximately 48 weeks
RP2D will be assessed based on MTD.
次要结局
- Pharmacokinetic(PK) of maximum serum Concentration (Cmax)(From baseline up to 4 weeks post-dose)
- Progression-free survival(PFS) rate at 6 months(From baseline up to 6 months)
- Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast)(From baseline up to 4 weeks post-dose)
- Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax)(From baseline up to 4 weeks post-dose)
- Disease control rate(DCR)(From baseline up to disease progression, approximately 48 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal CancerMetastatic Colorectal CancerNCT05093907BeyondBio Inc.27
已完成
1 期
Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)NeoplasmsNCT01976741Bayer168
已完成
1 期
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 ProteinCancers With HER2 ExpressionNCT04147819Bayer14
已完成
1 期
Open Label Study of BAY1082439 in Patients With Advanced CancerNeoplasmsNCT01728311Bayer60
撤回
1 期
Combination Therapy of SyB C-1101 and Azacytidine in Patients With Myelodysplastic SyndromeMyelodysplastic SyndromeNCT02783547SymBio Pharmaceuticals