A Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of AK146D1 in Combination With AK112 or Other Anticancer Therapies in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 348
- 试验地点
- 1
研究概览
简要总结
This is a phase II clinical study evaluating the safety, tolerability, pharmacokinetics and antitumor efficacy of AK146D1 in combination with AK112 or other anticancer therapies in patients with advanced Non-Small Cell Lung Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Be able to understand and voluntarily sign the written informed consent form.
- •Aged of ≥ 18 years and ≤75 years.
- •ECOG PS 0 or
- •The expected lifespan is ≥3 months.
- •Patients with histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) who are not eligible for curative surgical resection and cannot receive definitive concurrent or sequential chemoradiotherapy.
- •At least one measurable non-brain lesion according to RECIST v1.
- •Have sufficient organ function.
- •Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.
排除标准
- •NSCLC mixed with a component of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma.
- •Having other active malignancies within 3 years.
- •Currently participating in another interventional clinical study.
- •Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- •Having received any treatment targeting Trop2 or Nectin
- •Prior chemotherapy or antibody-drug conjugate (ADC) therapy targeting topoisomerase I inhibitors.
- •Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks (or 5 half-lives of the drug, whichever is longer) prior to the first dose.
- •Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
- •Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
- •Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
- •Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.
- •Known to be positive for HIV and other infections.
- •Previous history of severe hypersensitivity reactions.
- •Live attenuated vaccines were received within 4 weeks.
- •Subjects with a history of mental illness and incapacitated or limited capacity.
- •Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
研究组 & 干预措施
Arm A
Participants in this group will receive AK146D1 combined with AK112 and platinum as i.v. infusion.
干预措施: AK112 Injection (Drug)
Arm C
Participants in this group will receive AK146D1 combined with AK112 as i.v. infusion.
干预措施: AK146D1 for injection (Drug)
Arm A
Participants in this group will receive AK146D1 combined with AK112 and platinum as i.v. infusion.
干预措施: Platinum chemotherapy (Drug)
Arm B
Participants in this group will receive AK146D1 combined with osimertinib.
干预措施: Osimertinib (Drug)
Arm A
Participants in this group will receive AK146D1 combined with AK112 and platinum as i.v. infusion.
干预措施: AK146D1 for injection (Drug)
Arm B
Participants in this group will receive AK146D1 combined with osimertinib.
干预措施: AK146D1 for injection (Drug)
Arm C
Participants in this group will receive AK146D1 combined with AK112 as i.v. infusion.
干预措施: AK112 Injection (Drug)