NCT06938321招募中1 期
An Open Label, Multicenter, Phase Ib/II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
Akeso1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年4月30日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Number of subjects with dose limiting toxicities (DLTs)
研究概览
简要总结
There're 2 parts in this interventional study:
- The goal of phase Ib trial is to evaluate the safety and tolerability of AK130 in combination with AK112 therapy for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced biliary tract cancer (BTC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial.
- The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination with AK130 therapy or monotherapy in the treatment of advanced BTC.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 and willing to provide written informed consent.
- •Have a life expectancy of at least 3 months.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subjects with histologically and/or cytologically confirmed advanced or metastatic biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma; excluding ampullary carcinoma), who have experienced treatment failure following prior first-line systemic therapy.
- •According to RECIST v1.1, there is at least one untreatable measurable lesion, or a measurable lesion with clear imaging progression after local treatment, suitable for repeated and accurate measurement.
- •Has adequate organ function.
- •All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
- •Able to to comply with all requirements of study participation (including all study procedures).
排除标准
- •Except for BTC, the subjects had other malignant tumors within the 3 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ.
- •There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
- •There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- •Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
- •There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
- •History of severe bleeding tendency or coagulation dysfunction.
- •Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
- •Any arterial or severe venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to the first administration of medication.
- •Pregnant or lactating female subject.
- •Any prior or concurrent disease, treatment, or laboratory test abnormality that may confuse study results, affect subjects' full participation in the study, or may not be in their best interest to participate.
研究组 & 干预措施
AK112 in combination with AK130
Experimental
干预措施: AK112 (Drug)
AK112 in combination with AK130
Experimental
干预措施: AK130 (Drug)
AK112
Experimental
干预措施: AK112 (Drug)
结局指标
主要结局
Number of subjects with dose limiting toxicities (DLTs)
时间窗: During the first three weeks.
DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.
Number of subjects with adverse events (AEs)
时间窗: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Objective Response Rate (ORR) (Phase II)
时间窗: Through study completion, an average of 2 years.
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
次要结局
- Time to response (TTR)(From date of randomization until the date of first documented response, assessed up to 24 months)
- Progression Free Survival (PFS)(Through study completion, an average of 2 years.)
- Overall survival (OS)(Through study completion, an average of 2 years.)
- Objective Response Rate (ORR) (Phase Ib)(Through study completion, an average of 2 years.)
- Disease control rate (DCR)(Through study completion, an average of 2 years)
- Duration of Response (DoR)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A Study of MEK162 and AMG 479 in Patients With Selected Solid TumorsMetastatic Pancreatic AdenocarcinomaBRAF Mutated MelanomaNCT01562899Pfizer77
招募中
1 期
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal CancerNCT06873763STCube, Inc.52
终止
1 期
Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05571969Allarity Therapeutics14
招募中
1 期
A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)NCT05934513Genfleet Therapeutics (Shanghai) Inc.95
进行中（未招募）
1 期
A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's LymphomaNon-Hodgkin LymphomaNCT05950165Cho Pharma Inc.37