A Phase I Study of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-programmed cell death protein 1 (PD-1) antibody.
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
- •1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- •2 Age ≥ 18; Eastern Cooperative Oncology Group perfomance status score: 0-2; at least 3 months expected survival period.
- •3 Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
- •4 Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 per CTCAE v5.0 except for AEs not constituting a safety risk by investigator judgment.
- •5 Must have adequate organ and bone marrow function.
- •6 Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for at least 6 months after the last dose of assigned treatment.
排除标准
- •1 Subjects with other malignancies currently or suffered within 3 years. The following two conditions can be enrolled: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- •2 Sujects with multiple factors affecting oral administration；
- •3 Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment；
- •4 Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before first administration；
- •5 Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.
研究组 & 干预措施
TQB3602 Capsule + AK105 Injection
TQB3602 capsule administered orally on day 1, 8 in 21-day cycle; every three weeks intravenous (IV) for one times of AK105 injection.
干预措施: TQB3602 Capsule + AK105 Injection (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: During the first 21 days
DLT will be assessed during the first 21 days of treatment for dose-escalation 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 (21 days) of treatment.
Recommended phase II dose (RP2D)
时间窗: Up to Cycle 28 (Cycle Length= 21 days)
The RP2D was the maximum tolerated dose (MTD) or less.
Maximum tolerated dose (MTD)
时间窗: During the first 21 days
MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).
次要结局
- Number of patients with adverse events (AEs) and serious adverse events (SAEs)(From the time of informed consent signed to 90 days after the last dose)
- Progression-free survival (PFS)(up to 2 years)
- Overall survival (OS)(up to 5 years)
- Disease control rate (DCR)(up to 2 years)
- Duration of Response (DOR)(up to 2 years)