NCT05595460进行中（未招募）1 期
Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 15
- 主要终点
- RP2D
研究概览
简要总结
This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.
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
- •Age of at least 18 years at the time of signing the informed consent.
- •Cytologically or histologically confirmed ES-SCLC (American Joint Committee on Cancer [AJCC] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and PD-L1 inhibitor therapy. It is acceptable to omit the first dose of PD-L1 inhibitor therapy due to logistical reasons if receiving SoC during or prior to the start of the screening period.
- •Subject is a candidate for therapy with SoC which includes:
- •Carboplatin for a maximum of 4 cycles
- •Etoposide for a maximum of 4 cycles
- •Atezolizumab
- •At least 1SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and ≥50% of RECIST v1.1 measurable metastatic lesions must be SSTR-imaging positive.
- •Adequate hematologic, renal and hepatic function
排除标准
- •Prior exposure to immune-mediated therapy,
- •Known active or suspected autoimmune disease or any condition requiring systemic treatment with immunosuppressive medications within 14 days prior to first dose of study drug
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. Note: History of radiation pneumonitis is permitted.
- •Severe infection within 4 weeks and/or treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment.
- •Prior allogeneic stem cell or solid organ transplantation.
- •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab.
- •Radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care is allowed but must be completed >2 weeks prior to first dose of study drug.
- •Significant cardiovascular disease and/or resistant hypertension
- •Subjects with previously treated central nervous system (CNS) metastases who have not recovered from acute side effects of radiotherapy.
研究组 & 干预措施
RYZ101 + SoC
Experimental
干预措施: RYZ101 Dose Level 1 (Drug)
RYZ101 + SoC
Experimental
干预措施: RYZ101 Dose Level 2 (Drug)
RYZ101 + SoC
Experimental
干预措施: RYZ101 Dose Level 3 (Drug)
RYZ101 + SoC
Experimental
干预措施: RYZ101 Dose Level -1 (Drug)
RYZ101 + SoC
Experimental
干预措施: Atezolizumab (Drug)
RYZ101 + SoC
Experimental
干预措施: Etoposide (Drug)
RYZ101 + SoC
Experimental
干预措施: Carboplatin (Drug)
结局指标
主要结局
RP2D
时间窗: 42 days of study treatment
RP2D as determined by incidence rate of DLTs
Safety and tolerability of RYZ101 in combination with SoC
时间窗: Up to 50 months
Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings
次要结局
未报告次要终点
研究者
研究点 (15)
Loading locations...
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