NCT04172506已完成1 期
A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors
Akeso1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年9月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and signed informed consent.
- •Aged over 18 and less than 75 years at the time of signing the informed consent form, both female and male.
- •ECOG PS is 0-
- •The expected survival time is ≥ 3months
- •Histologically or cytologically confirmed selected advanced solid tumor.
- •Subject must have at least one measurable lesion according to RECIST Version1.
- •Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy.
- •Adequate organ function.
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
- •Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
- •Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other requirements for the study.
排除标准
- •Had received experimental drug or used experimental device in the past within 4 weeks prior to the first dose of study drug.
- •Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization] within 4 weeks prior to the first dose of study drug.
- •Had received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, etc.), or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways (such as ICOS, CD40, CD137, GITR, OX40 antibody or drug), immunocytotherapy, therapeutic antibody, etc.).
- •Toxicity from previous anti-cancer therapy has not been alleviated or resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria.
- •Patients with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
- •Active or previously recorded inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea).
- •Patients with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Large surgical procedures (defined by researchers as open biopsy, severe trauma, etc.) were performed within 28 days prior to the first dose of study drug.
- •Known history of interstitial lung disease.
- •Patients with untreated chronic hepatitis B or HBV DNA exceeding 1000IU/mL or active hepatitis C. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.
- •Patients with active tuberculosis (TB).
- •History of known primary immunodeficiency virus infection or positive HIV testing.
- •Severe infections within 4 weeks prior to the first dose of study drug, including but not limited to complications, sepsis or severe pulmonary infections requiring hospitalization.
- •Patients with meningeal metastasis, spinal cord compression, pia mater disease or active brain metastasis. Patients who meet one of the following requirements may be enrolled: a). No central nervous system metastasis symptoms and signs, such as neurological dysfunction, epilepsy or other central nervous system metastasis before admission. No edema around the lesion found by imaging examination, and no brain metastasis more than 1.5 cm in length. b). Patients with central nervous system metastasis had received treatment and achieved asymptomatic status (e.g. without neurological dysfunction, epilepsy or other typical central nervous system metastasis symptoms and signs)
- •Patients with pleural effusion, pericardial effusion or ascites that could not be controlled stably by repeated drainage or other methods as judged by the investigator.
- •Receipt of live, attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live, attenuated vaccine during the study.
- •Known history of sever hypersensitivity reaction to other monoclonal antibodies.
- •Known history of allergy or hypersensitivity to AK105 or any of its components
- •Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results.
研究组 & 干预措施
AK105
Experimental
AK105 200 mg, every 2 weeks
干预措施: AK105 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
次要结局
- Disease control rate (DCR)(Up to 2 years)
- Number of participants with adverse events (AEs)(the time of informed consent signed through 90 days after the last dose of AK105)
- Progression-free survival (PFS)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
- Minimum observed concentration (Cmin) of AK105 at steady state(From first dose of AK105 through to 90 days after last dose of AK105)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK105 through to 90 days after last dose of AK105)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing TumorsPart 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal CancerPart 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal CancerNCT04482309AstraZeneca477
进行中（未招募）
2 期
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating MutationsAdvanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,BreastNCT04639219AstraZeneca102
招募中
2 期
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BCLocally Advanced or Metastatic Breast CancerNCT06439771MediLink Therapeutics (Suzhou) Co., Ltd.180
暂停
2 期
Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic LeukemiaB-cell Chronic Lymphocytic LeukemiaNCT01982175Shanghai Zhangjiang Biotechnology Limited Company120
终止
1 期
TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid TumorsOsteosarcomaOther Solid TumorsNCT06438783Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.20