A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male or female participants between 18 and 75 years old.
- •Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):
- •Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.
- •Cohort 2~3: participant has received no prior systemic treatment.
- •Agree to provide fresh or archival tumor tissue for biomarker analysis.
- •Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy >= 12 weeks.
- •Has adequate organ and bone marrow functions.
- •Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
- •Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.
- •Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.
排除标准
- •The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
- •Has previously received medications with the same target or the same toxins.
- •Presence of spinal cord compression or clinically active central nervous system metastases.
- •Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
- •Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.
- •With peripheral neuropathy of grade ≥
- •History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.
- •Presence of uncontrolled concurrent diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Severe active peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction, etc.
- •Serious or uncontrolled heart disease or clinical symptoms requiring treatment.
- •History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
- •Clinical severe lung damage caused by concurrent lung disease.
- •Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion.
- •Pregnant or lactating women.
- •Rapid disease deterioration in the screening process.
研究组 & 干预措施
2. SKB500 +KL-A167+Carboplatin
Participants will receive KL-A167 followed by SKB500 with Carboplatin
干预措施: KL-A167 Injection (Drug)
1. SKB500+KL-A167
Participants will receive KL-A167 followed by SKB500
干预措施: SKB500 Powder for Injection (Drug)
1. SKB500+KL-A167
Participants will receive KL-A167 followed by SKB500
干预措施: KL-A167 Injection (Drug)
2. SKB500 +KL-A167+Carboplatin
Participants will receive KL-A167 followed by SKB500 with Carboplatin
干预措施: SKB500 Powder for Injection (Drug)
3. SKB500+KL-A167+Carboplatin+Etoposide
Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide
干预措施: SKB500 Powder for Injection (Drug)
3. SKB500+KL-A167+Carboplatin+Etoposide
Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide
干预措施: KL-A167 Injection (Drug)
2. SKB500 +KL-A167+Carboplatin
Participants will receive KL-A167 followed by SKB500 with Carboplatin
干预措施: Carboplatin Injection (Drug)
3. SKB500+KL-A167+Carboplatin+Etoposide
Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide
干预措施: Carboplatin Injection (Drug)
3. SKB500+KL-A167+Carboplatin+Etoposide
Participants will receive KL-A167 followed by SKB500, Carboplatin with Etoposide
干预措施: Etoposide Injection (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: up to 24 months
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Progression-free survival (PFS)
时间窗: up to 24 months
Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
次要结局
- Objective Response Rate (ORR)(up to 24 months)
- Duration of response (DOR)(up to 24 months)
- Disease control rate (DCR)(up to 24 months)
- Overall Survival (OS)(up to 24 months)
- Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB500-ADC, SKB500-TAB and free payload(Cycle 1-4, 6, 8,12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months)
- Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB500-ADC, SKB500-TAB and free payload(Cycle 1-4, 6, 8,12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months, up to 24 months)
- Anti-drug Antibodies (ADA) for SKB500(Cycle 1-4, 6, 8, 12, 16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, (each cycle is 21 days), up to 24 months)