A Multicenter, Open Phase 1b Study to Evaluate the Efficacy and Safety of QL1706 Injection in Patients With Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
This a multi-center, open-label, non-randomized phaseⅠb trail. The purpose of this study was to evaluate the efficacy and safety of QL1706 in patients with advanced solid tumors and to investigate the immunogenicity and pharmacokinetic characteristics of QL1706.
详细描述
The study was divided into screening/baseline, treatment and follow-up periods. Efficacy assessment and safety monitoring will be conducted throughout the study period.
Subjects will continue study treatment until disease progression occurs (unless the investigator believes there is a sustained clinical benefit) or other criteria for discontinuing study treatment are met, whichever occurs first.
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
- •Subjects participate voluntarily and sign informed consent.
- •Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors，such as lung cancer, nasopharyngeal carcinoma, cervical cancer, hepatocellular carcinoma, kidney cancer etc., failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery
- •Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.
- •Eastern Cooperative Oncology Group (ECOG) score was 0 or
- •The extension of life is more than 3 months
- •Vital organs' function is adequate for enrolling
- •Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.
- •Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.
排除标准
- •Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.
- •There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.
- •Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.
- •Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study
- •Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period
- •Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor.
- •Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs
- •Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) >2000 IU/ mL or 10^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive
研究组 & 干预措施
QL1706 injection
This clinical trail is a single arm study, all the patients that meet the entry criteria will receive treatment until disease progression occurs or meet other criteria for the discontinuation of treatment. QL1706 will be administered by intravenous infusion, 5 mg/kg, Q3W.
干预措施: QL1706 injection (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: up to 24 weeks
ORR includes complete response (CR) and partial response (PR) cases. According to RECIST V1.1, the first appearance of PR or CR requires additional imaging to confirm the lesion at ≥4 weeks.
次要结局
- overall survival time (OS)(From date of enrollment until the date of death from any cause, assessed up to 24 months)
- progression-free survival (PFS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- disease control rate (DCR)(up to 24 weeks)
- adverse event (AE)(up to 90 days after the last QL1706 injection is administered.)