NCT07467629招募中1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5212 Monotherapy in Participants With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.
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
- •Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.
- •Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
- •Age ≥ 18 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
- •Life expectancy ≥ 3 months.
- •Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and/or MRI.
- •7. Acceptable laboratory parameters:
- •Absolute neutrophil count ≥ 1,500/μL.
- •Platelet count ≥ 100 × 1000/μL
- •Hemoglobin ≥ 9.0 g/dL.
- •Albumin ≥ 3 g/dL.
- •ALT/AST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.）
- •Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.
- •a calculated or measured creatinine clearance ≥60 mL/minute.
- •Identification of an archival tumor sample (i.e., tissue block [formalin-fixed paraffin-embedded] or a series of approximately 10-15 slides).
排除标准
- •History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;
- •Untreated or active brain metastases, including leptomeningeal carcinomatosis;
- •Prior systemic anti-cancer therapy within specified windows;
- •Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;
- •Clinically significant cardiovascular disease;
- •Uncontrolled systemic infection or active tuberculosis;
- •Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years;
- •Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.
研究组 & 干预措施
QLS5212 Dose Escalation
Experimental
干预措施: QLS5212 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: From First Patient Dosed to end of Escalation (up to 14 months).
Dose-limiting Toxicity (DLT)
时间窗: From enrollment to 21 days of treatment.
Recommended Phase 2 dose (RP2D)
时间窗: From First Patient Dosed to end of Escalation (up to 14 months).
Incidence of Treatment-Emergent Adverse Events
时间窗: From enrollment of the first participant to 30 days after last dose of treatment or End of Treatment [EOT] visit (whichever is later).
次要结局
- Maximum Plasma Concentration of QLS5212(From Day 1 of dosing through 7 days after last dose.)
- Area Under the Curve (AUC) of QLS5212(From Day 1 of dosing to 7 days after last dose.)
- Circulating anti-drug antibodies (ADA) of QLS5212(From Day 1 of dosing to 7 days after last dose.)
研究者
研究点 (1)
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