NCT06223256招募中1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity（DLT）
研究概览
简要总结
This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion.
Dose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.
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
- •Patients ≥18 years old, should have fully understood the study and voluntarily signed an informed consent form.
- •Patients with pathologically diagnosed advanced solid tumors with positive expression of CLDN
- •Stage I: Patients have failed or cannot tolerate standard of care, or without standard treatment; Stage Ⅱ: Previously treated advanced solid tumors.
- •Be able to provide previously well-preserved tumor tissue sections, or agree to undergo tumor tissue biopsy for central laboratory biomarker testing.
- •At least one measurable target lesion according to RECIST 1.
- •ECOG performance status of 0 or 1 at screening.
- •Life expectancy ≥3 months.
- •Adequate organ function within 7 days prior to the first dose defined as: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥100×10^9/L;. Hemoglobin (HGB) ≥90 g/L; Serum creatinine ≤ 1.5 × ULN or Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥50 mL/min; Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN when patients with Gilbert's disease); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement is known).
- •Serum pregnancy test for women of childbearing potential (WOCBP) is negative within 7 days prior to the first dose of the investigational drug. The patient and his/her spouse must agree to use adequate contraception from signing of informed consent form (ICF) to 3 months after the last dose, during which women should be non-lactating and men should refrain from donating sperm.
排除标准
- •Previously received CLDN6-targeted or CD137-targeted treatment.
- •Known uncontrolled central nervous system (CNS) cancer including CNS metastasis, meningeal metastasis, or spinal cord compression.
- •Patients with high risk of bleeding due to tumor invasion of important arteries.
- •Has uncontrolled serous cavity effusion (such as pleural effusion, abdominal effusion, or pericardial effusion, etc) requiring repeated drainage.
- •Has adverse events due to previous anti-tumor treatments that have not yet recovered to ≤Grade 1 according to NCI-CTCAE v5.0;
- •Developed immune-related adverse events (irAE) of grade ≥3 (CTCAE 5.0) with prior immunotherapy
- •Known to exist any other malignant tumor requiring intervention.
- •Have received anti-tumor treatments (such as chemotherapy, targeted therapy, biological therapy, etc.) or any other investigational drugs or treatments within 4 weeks or 5 half-lives, whichever is shorter.
- •Have received a live viral vaccine within 4 weeks before the first dose of study drug.
- •Have received immunosuppressive medications within 2 weeks prior to the first dose of study drug.
- •Have active or serious bacterial, fungal, or viral infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose of study drug.
- •Have received radiation therapy or other localized palliative treatment within 2 weeks before the first dose of study drug.
- •Have undergone major surgery within 4 weeks before the first dose of study drug, or scheduled to have major surgery during the study.
- •Have a history of serious cardiovascular disease.
- •Have active or history of autoimmune diseases.
- •A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
- •Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis.
- •Hypersensitive to humanized monoclonal antibody products.
- •Women during lactation or pregnancy.
- •Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration.
- •Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.
研究组 & 干预措施
NBL-028
Experimental
Patients will be treated with NBL-028 at starting dose of 0.01 mg/kg in dose escalation stage. In dose expansion stage, patients will be treated with NBL-028 at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage.
干预措施: NBL-028 (Drug)
结局指标
主要结局
Dose-limiting toxicity（DLT）
时间窗: Up to approximately 1 years
Dose-limiting toxicity
Incidence and severity of adverse events (AE) and serious adverse events (SAE) Incidence, nature, and severity of adverse events will be graded according to the NCI CTCAE v5.0
时间窗: Up to approximately 3 years
adverse events (AEs) and severe adverse events (SAEs)
Maximum Tolerated Dose（MTD） of NBL-028
时间窗: Up to approximately 1 years
Maximum Tolerated Dose
Recommended Phase 2 dose（RP2D）
时间窗: Up to approximately 1 years
Recommended Phase 2 dose
次要结局
- Overall response rate (ORR).Determined using RECIST v1.1 criteria.(Up to approximately 3 years)
- Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Cmax.(Up to approximately 3 years)
- Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Area under curve（AUC）.(Up to approximately 3 years)
- Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Tmax.(Up to approximately 3 years)
- Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter t1/2.(Up to approximately 3 years)
- anti-drug antibody（ADA）(Up to approximately 3 years)
- Disease control rate（DCR）(Up to approximately 3 years)
- Duration of response (DoR)(Up to approximately 3 years)
- Progression free survival（PFS）(Up to approximately 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of FZ-AD004 in Patients With Advanced Solid TumorsAdvanced and Metastatic Solid TumorNCT05914545Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.121
终止
1 期
A single centre, open label, first in human, phase 1 dose escalating study to evaluate the safety, tolerability and preliminary efficacy of an autologous cancer vaccine, RGSH4K, administered intradermally in patients with advanced cancers.ACTRN12615000516583Regeneus Ltd13
已完成
1 期
Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101 Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second RelapsePatients With Multiple Myeloma Experiencing aFirst or Second RelapseNCT01217203Innate Pharma15
Unknown
1 期
MAX-10181 in Patients With Advanced Solid TumorSolid TumorNCT05196360Maxinovel Pty., Ltd.80
已完成
1 期
Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell TherapyRefractory Diffuse Large B-cell LymphomaRefractory Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Diffuse Large B-Cell LymphomaRefractory High Grade B-Cell LymphomaRefractory Transformed Follicular Lymphoma to Diffuse Large B-Cell LymphomaHigh-grade B-cell LymphomaDLBCL Arising From Follicular LymphomaPrimary Mediastinal Large B-cell LymphomaNCT05075603NeoImmuneTech17