NCT07169994招募中1 期
A Multi-center, Open-Label, Phase Ib/II Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy 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
- 414
- 试验地点
- 19
- 主要终点
- Nature and frequency of dose-limiting toxicity (DLT)
研究概览
简要总结
This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
- •Able and willing to comply with protocol visits and procedures
- •Aged between 18 to 75 years
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Previously treated by standard treatment or have not been treated for metastatic setting;
- •Adequate organ and bone marrow function.
- •Have at least 1 extracranial measurable tumor lesion.
- •Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.
排除标准
- •With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
- •Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
- •Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
- •The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
- •Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
- •Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
- •Prior treatment with systemic steroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
- •Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
- •With meningeal metastasis or cancerous meningitis.
- •With brain metastasis or spinal cord compression.
- •Patients with uncontrolled or clinically significant cardiovascular diseases.
- •Clinically significant complicated pulmonary disorders.
- •Patients diagnosed with Gilbert syndrome.
- •Those with uncontrolled effusion in the third space requiring repeated drainage.
- •With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.
- •With serious infection before the first dose.
- •With known human immunodeficiency virus (HIV) infection.
- •With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
- •Unrelieved toxicity of previous anti-tumor therapy.
- •With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
- •Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
- •With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.
研究组 & 干预措施
YL202 in combination with Toripalimab
Experimental
Part 1 (dose escalation stage and backfill stage) & Part 3 (dose expansion stage): YL202 for injection in combination with Toripalimab injection
干预措施: YL202 for injection; Toripalimab injection (Drug)
YL202 in combination with Furmonertinib Mesilate
Experimental
Part 2 (dose escalation stage and backfill stage) & Part 4 (dose expansion stage): YL202 for injection in combination with Furmonertinib Mesilate Tablets
干预措施: YL202 for injection; Furmonertinib Mesilate Tablets (Drug)
结局指标
主要结局
Nature and frequency of dose-limiting toxicity (DLT)
时间窗: 21 days after the first dose was administered to each subject.
The purpose of DLT is to find maximum tolerated dose (MTD).
Nature and frequency of adverse events (AEs)
时间窗: 42 days after the end of treatment (EOT).
Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.
次要结局
- Objective response rate (ORR)(Up to approximately 3 years.)
- Characterize Pharmacokinetics (PK) parameter AUC(Up to approximately 3 years)
- Characterize Pharmacokinetics (PK) parameter Cmax(Up to approximately 3 years)
- Characterize Pharmacokinetics (PK) parameter Ctrough(Up to approximately 3 years)
- Characterize Pharmacokinetics (PK) parameter Tmax(Up to approximately 3 years)
- Characterize Pharmacokinetics (PK) parameter CL(Up to approximately 3 years)
- Characterize Pharmacokinetics (PK) parameter Vd(Up to approximately 3 years)
- Characterize Pharmacokinetics (PK) parameter t1/2(Up to approximately 3 years)
- Immunogenicity endpoint: Incidence of anti-YL202 antibody (ADAs).(Up to approximately 3 years)
研究者
研究点 (19)
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