A Phase Ib/II Study of AK112#PD-1/VEGF Bispecific Antibody# in Combination With AK117#Anti-CD47 Antibody# in Advanced Malignant Tumors

Akeso1 个研究点分布在 1 个国家目标入组 154 人开始时间: 2022年5月4日最近更新: 2026年3月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 154
试验地点: 1
主要终点: Objective Response Rate (ORR)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant 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

•18 to 75 years old.
•Have a life expectancy of at least 3 months.
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Phase Ib: Histologically or cytologically confirmed selected advanced solid tumor.
•Phase II: Subjects were patients with recurrent/metastatic HNSCC diagnosed histologically and/or cytologically that could not be completely resected surgically and could not be treated with radical simultaneous radiotherapy, or local and or neck recurrence after radical surgery that had progressed with radiotherapy or were unsuitable for radiotherapy.
•Cohort 1 and 2 :
•Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for previous recurrent or metastatic stage and has positive PD-L1 expression (CPS ≥ 1); for subjects who have received previous adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, if disease progression occurs after the end of the last chemotherapy session ≥ 6 months, are eligible to participate in this cohort.
•Cohort 3: Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent, or radical radiotherapy for locally advanced disease, are eligible to participate in this cohort if disease progression occurs ≥6 months after the end of the last chemotherapy treatment.
•Cohort 4: Recurrent or metastatic nasopharyngeal carcinoma that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, they are eligible for this cohort if disease progression occurs ≥ 6 months after the end of the last chemotherapy treatment. Note: Subjects with recurrent or residual primary foci after radiotherapy are excluded, and subjects with adenocarcinoma or sarcoma of the nasopharynx are excluded.
•Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
•Has adequate organ function.

排除标准

•Undergone major surgery within 30 days prior to the first dose of study treatment.
•Active central nervous system (CNS) metastases.
•History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
•Active Hepatitis B or Hepatitis C.
•Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
•History of severe bleeding tendency or coagulation disorder.

研究组 & 干预措施

Phase Ib#Dosage regimen 1#

Experimental

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW)

干预措施: AK112 (Drug)

Phase Ib#Dosage regimen 1#

Experimental

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW)

干预措施: AK117 (Drug)

Phase Ib#Dosage regimen 2#

Experimental

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW)

干预措施: AK112 (Drug)

Phase Ib#Dosage regimen 2#

Experimental

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW)

干预措施: AK117 (Drug)

Phase II#Cohort 1#

Experimental

Head and neck squamous cell carcinoma (HNSCC): AK112 (20 mg/kg Q3W)

干预措施: AK112 (Drug)

Phase II#Cohort 2#

Experimental

HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)

干预措施: AK112 (Drug)

Phase II#Cohort 2#

Experimental

HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)

干预措施: AK117 (Drug)