Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.
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
- •1 Age: 18-75 years old;ECOG PS score: 0~1;The expected survival is over 3 months
- •2 Patients with advanced melanoma diagnosed histologically and/or cytologically
- •3 At least one measurable lesion was confirmed according to RECIST 1.1 criteria
- •4 Major organs are functioning normally
- •5 Female subjects of reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study;Negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;Male subjects should agree to use contraception during the study and for six months after the end of the study period
排除标准
- •1 Present or present with other malignant tumors within 3 years prior to first use
- •2 Unalleviated toxicity above CTCAE grade 1 due to any prior treatment
- •3 Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration
- •4 A wound or fracture that has not healed for a long time
- •5 Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders
- •6 Subject with any severe and/or uncontrolled disease
- •7 Prior chemotherapy within 3 weeks prior to initial drug use, and prior radiotherapy or other antineoplastic drugs within 2 weeks prior to initial drug use
- •8 Those who have participated in and used other antitumor clinical trials within 4 weeks prior to the first drug use
研究组 & 干预措施
TQB2618 injection combined with Toripalimab injection
TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle.
干预措施: TQB2618 injection (Drug)
TQB2618 injection combined with Toripalimab injection
TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle.
干预措施: Toripalimab injection (Drug)
结局指标
主要结局
Dose-limiting toxicity
时间窗: Initial administration up to 21 days
Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose
phase II recommended dose
时间窗: At the end of phase I, 1 subject received the first dose up to 21 days
Optimal tolerated dose determined after the end of phase 1
objective response rate
时间窗: Baseline up to 96weeks
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)
次要结局
- Progression-Free Survival(disease progression before death,no more than 100 months)
- Disease Control Rate(Baseline up to 96 weeks)
- Overall Survival(No more than 100 months from the beginning of the first dose to death)