A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib 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
- •18Y≤Age≤75Y
- •Good Organ Function
- •Expected survival time ≥ 3 months
- •Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
- •Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
- •ECOG score 0-1;
- •Expected survival time of more than 3 months;
排除标准
- •Previous treatment with BRAF inhibitors or MEK inhibitors
- •Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- •Current or former patients with interstitial lung disease;
- •Active clinical severe infection;
- •A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
研究组 & 干预措施
ATC
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
干预措施: HLX 208 (Drug)
Primary brain tumor
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
干预措施: HLX 208 (Drug)
CRC(KRAS mutant)
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
干预措施: HLX 208 (Drug)
other solid tumor
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
干预措施: HLX 208 (Drug)
结局指标
主要结局
MTD
时间窗: from first dose to the end of Cycle 1 (each cycle is 21 days)
maximum tolerated dose
次要结局
- RP2D(from first dose to the end of Cycle 1 (each cycle is 21 days))
- Peak Plasma Concentration (Cmax) of HLX208(from first dose to the beginning of Cycle 4 (each cycle is 21 days))
- ORR(from first dose to the last patient was followed up for 6 month)
- Area under the plasma concentration versus time curve (AUC)of HLX208(from first dose to the beginning of Cycle 4 (each cycle is 21 days))