The Study to Evaluate the Safety, PK, and Preliminary Efficacy of BM201 Injection Combined With Radiotherapy in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors That Failed Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- DLT and MTD
研究概览
简要总结
This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment.
详细描述
This is a Phase I, open-label clinical study primarily designed to evaluate the safety and tolerability of BM201 injection in combination with radiotherapy in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable advanced or metastatic solid tumors, either refractory to standard therapy or ineligible for standard treatment.
- •ECOG performance status score of 0-2 point;
- •Expected survival of ≥3 months.
- •At least one measurable lesion by irRECIST criteria, and eligible for intratumoral injection.
- •Prior anti-tumor treatments should be paused for at least 4 weeks before trial initiation，with toxicity related to anti-cancer treatment recovered to ≤Grade
- •Adequate organ and bone marrow function
排除标准
- •Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4 weeks.
- •Allergic: History of hypersensitivity to active ingredients or any other components of the study medication; cumulative two or more allergies to contrast agents, other drugs, or food.
- •Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency virus (HIV), or syphilis.
- •Severe cardiac or cerebrovascular conditions, uncontrolled diabetes, hypertension not well-managed medically (systolic >140 mmHg and/or diastolic >90 mmHg), serious infections (active within 14 days before first drug administration/radiotherapy), active GI ulcers, and immune dysfunction.
- •Presence of other active malignancies or history thereof, except for previously managed non-invasive skin basal or squamous cell carcinomas with a 5-year recurrence-free interval, cervical carcinoma in situ, and ductal carcinoma in situ of the breast.
- •Uncontrolled third-space effusions such as pericardial, abdominal, or pleural within 2 weeks before the initial treatment.
- •Administration of corticosteroids within the preceding 2 weeks before initial treatment.
- •Receipt of vaccination within 2 weeks prior to initial therapy.
- •Participation in clinical trial involving drugs or biologics within 4 weeks before the initial treatment.
- •History of major surgery within 3 months prior to initial treatment or scheduled major surgery during the clinical trial period.
- •Prior blood donation or major hemorrhage (>450 mL) within 3 months before initial therapy, or intention to donate blood/blood components during or within 3 months after the trial.
- •Patients with difficult venous access or intolerance to venipuncture, and those unable to tolerate intratumoral injection.
- •Pregnant (positive pregnancy test) and lactating females.
- •Subjects planning pregnancy or gamete donation within 3 months post-consent and unwilling to practice effective contraception.
- •Patients deemed ineligible for enrollment by the investigator.
研究组 & 干预措施
Radiotherapy
Radiation：Hypofractionated radiotherapy
干预措施: Radiotherapy (Radiation)
BM201 injection combined with radiotherapy
BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy
干预措施: Radiotherapy (Radiation)
BM201 injection combined with radiotherapy
BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy
干预措施: BM201 injection (Drug)
结局指标
主要结局
DLT and MTD
时间窗: Up to 14 days after the initial treatment
Dose limiting toxicity and maximum tolerated dose
Pharmacokinetic (PK) parameters
时间窗: From pre-dose to 96 hrs post-dose
Maximum plasma concentration(Cmax) of the drug after administration
Number of patients with adverse events (AEs)
时间窗: From the first treatment to 42 days after the last treatment.
Number of patients with treatment-related adverse events (AEs)
次要结局
- ORR(Up to 42 days after the last treatment)
- Peripheral blood cytokine profiling in study participants.(From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.)
- The variation in peripheral blood tumor biomarker concentrations.(Up to 42 days after the last treatment)
- Other exploring outcomes(Up to 14 days after the initial treatment)