A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK112 in Patients With Advanced Malignant Tumors
概览
- 阶段
- 1 期
- 干预措施
- AK127 in combination with AK112
- 疾病 / 适应症
- Advanced Solid Tumors
- 发起方
- Akeso
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AEs)
- 状态
- 进行中（未招募）
- 最后更新
- 9天前
概览
简要总结
A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in combination with AK112 in Patients with Advanced Malignant Tumors
详细描述
The study consisted of two parts. The first part, Phase Ib is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity of AK127 in combination with AK112 in adult subjects with advanced solid tumor malignancies. The part, as a dose escalation phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK127 in combination with AK112, and describe Dose Limiting Toxicity (DLT).The second part, Phase II is to Evaluate the anti-tumor activity of AK127 in combination with AK112 in different tumor species cohorts.
研究者
入排标准
入选标准
- •Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- •Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or
- •Life expectancy ≥3 months；
- •Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
- •Adequate organ function.
- •Patients of childbearing potential must agree to use effective contraceptive measures.
排除标准
- •The patient has received prior immunotherapy against TIGIT target.
- •The patient had previously been treated with anti-PD -(L)1 and anti-VEGF targets.
- •Currently enrolled in any other clinical study.
- •Receipt of any anticancer therapy within 4 weeks prior to the first dose of Investigational drug;
- •Symptomatic central nervous system metastases.
- •Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
- •Active autoimmune disease requiring systemic treatment prior to the start of study treatment.
- •There is a history of major diseases 1 year prior to the first dose.
- •Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
- •Received chest radiation therapy prior to the first dose
研究组 & 干预措施
AK127 in combination with AK112
Subjects will receive AK127 in combination with AK112 by intravenous administration
干预措施: AK127 in combination with AK112
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Number of participants with a Dose Limiting Toxicity (DLT)
时间窗: During the first 3 weeks
DLTs will be assessed during the first 3 weeks of treatment for dose-escalation Ib phase and 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 first cycle (3 weeks) of treatment
Number of participants with ORR
时间窗: Up to 2 years
Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by investigator based on RECIST v1.1
Progression-Free Survival
时间窗: Up to 2 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.
次要结局
- Disease control rate(Up to 2 years)
- AUC of AK127 and AK112(Up to 2 years)
- Duration of response(Up to 2 years)
- Time to Progress(Up to 2 years)
- PK of AK127 and AK112(Up to 2 years)
- Cmax of AK127 and AK112(Up to 2 years)
- Cmin of AK127 and AK112 at steady state(Up to 2 years)
- The immunogenicity of AK127 and AK112(Up to 2 years)