A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a phase 1b/2, open label study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of KD6001 in combination with toripalimab in patients with advanced melanoma.
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
- •Being voluntary to sign the informed consent form.
- •Male or female, aged ≥ 18 years.
- •Patients whose estimated survival time is more than 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or
- •Histologically or cytologically confirmed advanced or metastatic melanoma, and the overall proportion of subjects with mucosal malignant melanoma will not exceed 22%.
- •At least one measurable lesion is used as the target lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).
- •The results of laboratory examination during the screening period suggest that the subjects have good organ function.
- •Male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods.
- •Good compliance and follow-up.
排除标准
- •Systematic treatment with antitumor drugs within 4 weeks prior to the start of this study.
- •Received immunotherapy (including PD-1/PD-L1 therapy and cell therapy) within 4 weeks prior to the start of this study.
- •Prior treatment with anti-CTLA-4 antibody.
- •Subjects with an active, known or suspected autoimmune disease.
- •Subjects with hepatitis (nonalcoholic steatohepatitis, alcoholic or drug-related, autoimmune hepatitis) and liver cirrhosis; active hepatitis B or hepatitis C.
- •Subjects with an active infection requiring systemic treatment.
- •Known history of testing positive for human immunodeficiency virus (HIV).
- •Subjects known to have active tuberculosis (TB).
- •Known to be allergic to KD6001 or Toripalimab and its components.
研究组 & 干预措施
KD6001+Toripalimab
KD6001 combined with toripalimab in patients with advanced melanoma
干预措施: KD6001 (Drug)
KD6001+Toripalimab
KD6001 combined with toripalimab in patients with advanced melanoma
干预措施: Toripalimab (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: Up to Day 21
DLTs will be assessed during the dose-escalation phase and are defined as the following treatment-related adverse events occurring within a total of 21 days after the first trial administration.
The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)
时间窗: Baseline to study completion up to 2 years
Evaluate the adverse events (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE 5.0).
Maximum tolerated dose (MTD)
时间窗: Up to Day 21
The maximum tolerated dose (MTD) of KD6001 combined with toripalimab
Recommended Phase II dose (RP2D)
时间窗: Up to Day 21
Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab
次要结局
- The antitumor activity of KD6001 in combination with Toripalimab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST 1.1(Baseline to study completion up to 2 years)
- The PK profile of KD6001 in combination with Toripalimab(Baseline to study completion up to 2 years)
- The immunogenicity of KD6001 in combination with Toripalimab(Baseline to study completion up to 2 years)