A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma
详细描述
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRJ1-3024 and will determine the recommended dose in China subjects with unresectable local advanced or metastatic melanoma.
PRJ1-3024 is a small molecular Hematopoietic progenitor kinase (HPK-1) inhibitor. It will be evaluated as an oral therapeutic that tests the anti-tumor activity in patients with unresectable or metastatic melanoma and has not yet been tested in humans.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). Patients who have progressed or relapsed after at least 1st-line systemic standard therapy.
- •Male or non-pregnant, non-lactating female subjects aged ≥18 years.
- •ECOG Performance Status 0~
- •Has at least 1 measurable lesion as defined by RECIST 1.1 criteria.
- •Life expectancy of ≥3 months, in the opinion of the Investigator.
- •Able to take oral medications and willing to record daily adherence to investigational product.
- •Adequate hematologic parameters.
- •Adequate renal and hepatic function
- •Able to understand and willing to sign a written informed consent form.
- •Consent to provide archived tissue specimen or tissue sample.
排除标准
- •History of another malignancy.
- •Known symptomatic brain metastases requiring >10 mg/day of prednisolone.
- •Significant cardiovascular disease.
- •Known active HBV, HCV, AIDS-related illness.
- •Has received a live vaccine within 30 days.
- •History of active autoimmune disorders, or ongoing immunosuppressive therapy.
- •Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade
- •Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
- •Prior treatment with other hematopoietic progenitor kinase 1 (HPK1) inhibitors.
- •Allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.
研究组 & 干预措施
Monotherapy Escalation / Monotherapy Backfill
Dose escalation arm with PRJ1-3024 which will begin with 3-6 subjects treated at the lowest planned dose level based on previous phase Ia study results. PRJ1-3024 is administered orally once daily. The starting dose is 300mg/day.
After the small dose escalation, one or two dose backfill group will be tested to further explore the efficacy and safety of China patients with unresectable local advanced or metastatic melanoma.
干预措施: PRJ1-3024 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 24 months
Estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Recommended phase 2 dose (RP2D)
时间窗: 24 months
To determine the RP2D in China advanced metastatic melanoma patients
次要结局
- Duration of response (DOR)(24 months)
- Progression-Free Survival (PFS)(24 months)
- Disease control rate (DCR)(24 months)
- Pharmacokinetic parameters (PK)(24 months)
- Incidence of adverse events (AEs)(24 months)
- Pharmacokinetic parameters(PK)(24 months)