NCT07304128
招募中
1 期
A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of PLB-002 (Anti-Claudin 6 ADC) in Adults With Advanced Solid Tumors
Primelink BioTherapeitics(ShenZhen) Limited2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月6日最近更新:
干预措施PLB-002
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Primelink BioTherapeitics(ShenZhen) Limited
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recommended Extension Dose and Recommended Phase 2 Dose (RP2D)
概览
简要总结
This study will test the safety, including side effects, and determine the characteristics of a drug called PLB-002 in participants with solid tumors.
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
- •Patients who meet all of the following criteria will be eligible to participate in the study:
- •Patient must have the ability to understand and voluntarily sign a written informed consent form (ICF) and must have signed ICF prior to any study procedure.
- •Adults aged 18 years or older.
- •Histologically or cytologically confirmed advanced solid tumors, including platinum-resistant ovarian cancer (including fallopian tube and primary peritoneal carcinoma), NSCLC, testicular cancer, and other solid tumors, who have failed or intolerant to available standard-of-care therapy or no standard treatment exists.
- •At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- •Performance status of Eastern Cooperative Oncology Group (ECOG) 0-
- •Expected survival of 3 months or longer.
- •Part 1: Available archived or fresh tissue for retrospective CLDN6 evaluation (patients in the backfill part are recommended to have positive CLDN6 staining results by immunohistochemistry \[IHC\] tested in the central laboratory before enrollment); Part 2: Positive CLDN6 staining of tumor tissue (archived or fresh) by IHC tested in the central laboratory.
- •Have adequate organ function, as indicated by the following laboratory parameters in below table.
- •Hematologic (no transfusion or hematopoietic stimulating factor treatment within 14 days) Neutrophils ≥ 1.5 × 109/L Platelets ≥ 100× 109/L Hemoglobin ≥ 90 g/L Hepatic function Total bilirubin ≤ 1.5×ULN (≤ 3.0×ULN for patients with Gilbert's syndrome or liver metastasis/ hepatocellular carcinoma) Alanine aminotransferase (ALT) ≤ 2.5×ULN (≤ 5.0×ULN for patients with liver metastasis/ hepatocellular carcinoma) Aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5.0×ULN for patients with liver metastasis/ hepatocellular carcinoma) Albumin ≥ 3.0 g/dL Renal function Creatinine clearance (Ccr) ≥ 60 mL/min (Ccr calculated according to Cockcroft-Gault formula) Coagulation function Activated partial thromboplastin time (aPTT), international normalized ratio (INR) and prothrombin time ≤ 1.5 × ULN (If patients are receiving anticoagulant therapy: stable doses of anticoagulants must be taken for ≥ 1 month, and the prothrombin time/aPTT/INR must be within the intended therapeutic range) Cardiac function Left ventricular ejection fraction (LVEF) ≥ 50%
排除标准
- •Patients who meet any of the following criteria will be excluded from participation in the study:
- •Patient received systemic chemotherapy, small molecular target therapy, hormone therapy, or herbal medication with anti-cancer indication within 2 weeks prior to start of study drug; or received biological anti-cancer products (such as antibody, antibody-drug conjugate \[ADC\]) within 4 weeks or 5 half-life time prior to start of study drug (whichever is shorter). For cytotoxic agents with major delayed toxicity (such as nitrosourea or mitomycin C), 6 weeks of washout are mandated.
- •Patients who have undergone radical radiotherapy within 4 weeks prior to the first dose of study drug, or have undergone brain stereotactic radiotherapy or whole brain radiotherapy within 4 weeks prior to the first dose of study drug, or have undergone palliative radiotherapy within 2 weeks prior to the first dose of study drug, or have used a radioactive drug (Strontium, Samarium, etc.) within 8 weeks prior to the first dose of the study drug.
- •Patient has received any other anti-cancer therapies targeting at CLDN
- •Patient has persisting toxicity of \> Grade 1 (NCI CTCAE v5.0) relating to prior anti-cancer therapy with the exceptions of alopecia and endocrine dysfunction which could be managed by replacement therapy.
- •Patient has active or uncontrolled infections, which require systemic treatment of antibiotics, antivirals, or antifungals, within 2 weeks prior to start of study drug.
- •Patient has meningeal metastases (symptomatic or asymptomatic), or has symptomatic or uncontrolled brain metastases or spinal cord compression. Patients with asymptomatic brain metastases (longest diameter of brain lesion ≤ 3 cm) can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (\> 20 mg prednisone or equivalent) for at least 4 weeks. If the patient has previously received antiepileptic treatment for central nervous system (CNS) metastases, antiepileptic medications should be discontinued for at least 2 weeks (14 days) prior to start of study drug.
- •Patient has uncontrolled pleural, peritoneal or pericardial effusion. Asymptomatic and stable effusion could be enrolled if any one of the following criteria is met:
- •If previous imaging indicated the presence of effusion, subsequent imaging shows a reduction, no change, or a slight increase of the effusion volume, and the patient has no effusion related symptom.
- •If puncture drainage or other therapy was performed, reexamination after an interval of 2 weeks at least shows no significant increase of the effusion volume, and the patient has no effusion related symptom.
研究组 & 干预措施
Part 2: Dose Expansion Study
Experimental
Patients with CLDN6 expression
干预措施: PLB-002 (Drug)
Part 1: Dose Escalation Study
Experimental
In the dose escalation part of the study, patients with advanced solid tumors will be treated with escalating doses of PLB-002.
干预措施: PLB-002 (Drug)
结局指标
主要结局
Recommended Extension Dose and Recommended Phase 2 Dose (RP2D)
时间窗: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Incidence and severity of adverse events and serious adverse events
时间窗: up to 2 years
Number and percentage of patients with adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), and dose-limiting toxicities (DLTs) ,according to NCI-CTCAE Version 5.0
次要结局
- Maximum Serum Concentration of PLB-002 (Cmax)(21 days)
- Time of Maximum Serum Concentration of PLB-002(Tmax)(21 days)
- Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for PLB-002(21 days)
- Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for PLB-002(84 days)
- Terminal Half-life (t1/2) of Serum PLB-002(84 days)
- Apparent volume of distribution during the terminal phase (Vz) of PLB-002(84 days)
- Clearance (CL) of PLB--002(84 days)
- Number of anti-drug antibody (ADA) Positive Participants(up to 2 years)
- QTc assessment (only applicable for Part 1)(up to 2 years)
- Objective Response Rate (ORR)(up to 2 years)
- Duration of Response (DOR)(up to 2 years)
- Disease control rate (DCR)(up to 2 years)
- Progression Free Survival (PFS)(up to 2 years)
- Overall Survival(up to 2 years)
研究者
研究点 (2)
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