A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- adverse events
研究概览
简要总结
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination with Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation.
The study includes Phase Ib (combination therapy with dose escalation stage) and Phase II (expansion stage). The study will includes a total of 4 cohorts:
Phase Ib will enroll subjects in 4 cohorts (cohorts 1-4). Subjects will be allocated to appropriate cohorts by the investigator according to specific indications and treated with the corresponding combination regimen for safety and tolerability assessment. The Bayesian optimal interval (BOIN) design will be used for dose escalation and MTD determination.
In Phase II, according to the results of the Phase Ib and SMC decision, 1-2 appropriate dose groups will be selected. In the dose group(s), the sample size (including subjects in the dose escalation stage) will be increased to 20 for each indication according to the cohort for expansion to further evaluate the efficacy of QLC1101 combination therapy in the treatment of subjects with advanced solid tumors harboring KRAS G12D mutations
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
- •Subjects confirmed advanced (metastatic or unresectable) solid tumors with KRAS G12D mutations.
- •Subjects who have failed or are unable to tolerate standard therapy, have no standard therapy, or refuse to receive standard therapy
- •The investigator confirms that the subject has at least one measurable lesion recorded by CT and/or MRI according to RECIST v1.1
- •ECOG PS score: 0 or 1
排除标准
- •Subjects who have been previously treated with inhibitors for KRAS G12D mutations
- •Subjects with known immediate or delayed hypersensitivity or idiosyncratic reaction to the components of the drug products used in the study
- •Subjects with known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis at screening
研究组 & 干预措施
QLC1101+QL1203
干预措施: QLC1101+QL1203 (Drug)
QLC1101+QL2107
干预措施: QLC1101+QL2107 (Drug)
QLC1101+QL1706
干预措施: QLC1101+QL1706 (Drug)
QLC1101+docetaxel
干预措施: QLC1101+docetaxel (Drug)
结局指标
主要结局
adverse events
时间窗: from first dose to 90 days after last dose
any untoward medical occurrence in a subject who received an investigational product, which can be manifested as any symptoms, signs, diseases, or laboratory test abnormalities, and do not necessarily have a causal relationship with the investigational product
次要结局
未报告次要终点