NCT07468396尚未招募1 期
A Phase I, Single-arm, Open-label, Multi-center Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GLR2037 in Patients With Metastatic Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of patients with Adverse Events as a measure of safety and tolerability of GLR2037
研究概览
简要总结
A Phase I Clinical Study of GLR2037 in Patients with Advanced Prostate Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged ≥ 18 years.
- •Histologically or cytologically confirmed adenocarcinoma of the prostate, without neuroendocrine or small cell features.
- •Metastatic bone or soft tissue lesions documented by imaging.
- •Prior surgical or medical castration.
- •Castrate level of testosterone at screening (≤ 50 ng/dL or 1.73 nmol/L).
- •Phase Ia and Ib: Prior treatment with at least one novel endocrine therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide, rezlutamide, etc.); patients in the dose-escalation phase of Phase Ia must have received at least one prior line of chemotherapy (e.g., docetaxel, cabazitaxel, etc.).
- •Evidence of disease progression during castration therapy in patients with metastatic prostate cancer at screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Adequate organ function meeting protocol-specified criteria.
- •Life expectancy ≥ 3 months.
- •Fertile male subjects and their partners must agree to use effective contraception (e.g., condoms) and refrain from donating sperm from the first dose of the study drug until 3 months after the last dose.
- •Willing to participate in this clinical trial, understand the study procedures, and have signed the informed consent form.
排除标准
- •Prior use of AR protein degraders.
- •Use of any other biological and/or immunological anti-tumor therapy (except castration therapy), targeted therapy, estrogen therapy, anti-androgen therapy, or other interventional investigational drug therapy; or receipt of systemic chemotherapy, systemic radiotherapy, or Chinese herbal/patent medicine with anti-tumor indications (as clearly stated in the package insert) within 4 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; or receipt of nitrosoureas, bicalutamide, or nilutamide within 6 weeks (or 5 half-lives, whichever is shorter) prior to the first dose.
- •3. Subjects who have used bisphosphonates or RANKL inhibitors for the treatment of bone metastases or bone-related diseases within 2 weeks prior to the first dose.
- •4. Have received systemic immunosuppressive therapy within 2 weeks prior to the first dose.
- •5. Use of strong inhibitors or inducers of CYP2C9 or CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to the first dose.
- •6. Patients with imaging evidence of brain or central nervous system metastases.
- •7. Severe bone injury caused by bone metastases of prostate cancer as judged by the investigator.
- •8. Concurrent uncontrolled hypertension at screening.
- •Presence of active cardiac disease or occurrence of arterial or venous thromboembolism within 6 months prior to the first dose.
- •10. History of other malignancies within 5 years prior to the first dose.
- •Have active hepatitis B (HBsAg positive and HBV-DNA titer ≥ 1×10³ copies/mL), hepatitis C (HCV antibody positive); or severe infections requiring antibiotics, antiviral or antifungal drugs for control.
- •12.History of immunodeficiency or organ transplantation. 13.Concurrent dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug administration and absorption.
- •14.Not recovered from adverse events of prior anti-tumor therapy to ≤ Grade 1 at screening.
- •15.Known allergy to any component or excipient of GLR
- •16.Subjects who have received palliative radiotherapy or major surgery (Grade 3-4) within 4 weeks prior to the first dose, or have participated in other drug clinical trials within 4 weeks prior to the first dose.
- •17.Plan to receive any other anti-tumor therapy during the study treatment period other than those specified in the protocol.
- •18.Any concomitant disease or other condition that, in the judgment of the investigator, poses a serious risk to the safety of the subject or could affect the subject's completion of the study. "
研究组 & 干预措施
GLR2037
Experimental
GLR2037 administered one daily(QD) for 28 day cycles.
干预措施: GLR2037 (Drug)
结局指标
主要结局
Number of patients with Adverse Events as a measure of safety and tolerability of GLR2037
时间窗: From signing of informed consent to 30 days after last dose (safety follow-up)
Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 6.0), timing, seriousness, and relationship to study drug.
Incidence of DLT of GLR2037
时间窗: 28 Days
First Cycle Dose limiting toxicities characterized by type, frequency, severity(as graded by NCI CTCAE version 6.0), timing, seriousness, and relationship to study drug
Incidence of laboratory abnormalities as a measure of safety and tolerability of GLR2037
时间窗: From signing of informed consent to 30 days after last dose (safety follow-up)
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
次要结局
- Assessment of pharmacokinetic (PK) parameter area under the concentration-time curve (AUC).(At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037)
- Assessment of pharmacokinetic parameter maximum concentration (Cmax).(At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037)
- Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)(At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037)
- To evaluate the clinical anti-tumor activity of GLR2037 in patients with mCRPC(12 Weeks)
研究者
研究点 (1)
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