NCT07061639尚未招募1 期
A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5133 Monotherapy in Subjects With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events and serious adverse events
研究概览
简要总结
The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion：
- Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. Phase 1 dose escalation will use ATD + BOIN, the maximum sample size for each dose group is 12. For Phase 1 PK expansion, 1 to 4 appropriate doses will be selected. After the DLT observation period in the selected dose group up to 12 subjects (including those subjects in the dose escalation stage) can be further enrolled for PK expansion.
- Phase 2: Evaluates QLS5133's anti-tumor efficacy in subjects with advanced solid tumors. at least 2 dose groups will be expanded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Aged ≥ 18 years on the day of signing the ICF, male or female;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
- •Measurable disease, per RECIST v1.1;
- •Adequate organ function;
- •Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
- •Left ventricular ejection fraction (LVEF) ≥ 50%;
排除标准
- •Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
- •Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
- •Progressive or symptomatic brain metastases;
- •Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
- •History of significant cardiac disease, or poorly controlled diabetes mellitus;
- •History of recurrent autoimmune diseases;
- •History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- •History of other active malignant tumors within 3 years before signing the informed consent form;
- •If female, is pregnant or breastfeeding;
- •Be allergic to any component of QLS5133 or its excipients.
研究组 & 干预措施
Monotherapy Dose Finding
Experimental
干预措施: QLS5133 (Drug)
PK expansion as Monotherapy
Experimental
干预措施: QLS5133 (Drug)
Cohort expansion as Monotherapy
Experimental
干预措施: QLS5133 (Drug)
结局指标
主要结局
Incidence and severity of adverse events and serious adverse events
时间窗: up to 2 years
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Objective Response Rate (ORR)
时间窗: up to 2 years
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Maximum tolerated dose (MTD)
时间窗: 28days
Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D)
时间窗: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
次要结局
- Maximum Serum Concentration of QLS5133 (Cmax)(21 days)
- Apparent Volume of Distribution (Vd) of QLS5133(63 days)
- Duration of Response (DOR)(up to 2 years)
- Maximum Serum Concentration of QLS5133 at Steady State (Cmax,ss)(63 days)
- Minimum Serum Concentration of QLS5133 at Steady State (Cmin,ss)(63 days)
- Clearance (CL) of QLS5133(63 days)
- 1 Year Overall Survival (1YOS)(1 years)
- Number of anti-drug antibody (ADA) Positive Participants(up to 2 years)
- Number of neutralizing antibody (Nab) Positive Participants(up to 2 years)
- Time of Maximum Serum Concentration of QLS5133 (Tmax)(21 days)
- Terminal Half-life (T1/2) of Serum QLS5133(63 days)
- Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5133(21 days)
- Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5133(63 days)
- Progression Free Survival (PFS)(up to 2 years)
- Time to Progression (TTP)(1 years)
- 2 Year Overall Survival (2YOS)(2 years)
研究者
研究点 (1)
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