An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants With an Objective Response Rate
研究概览
简要总结
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or metastatic HER2-expressing (IHC 2+ or 3+) or HER2-amplified solid tumors
- •Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
- •Tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows:
- •Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy
- •Gastric cancer and non-small-cell lung cancer (NSCLC): archival biopsy tissue taken within the past 12 months and after completion of last HER2-directed therapy, or a fresh biopsy
- •ECOG Performance Status of 0 or 1
- •Adequate hematologic, hepatic, renal, and cardiac function
排除标准
- •History of allergic reactions to certain components of study treatment therapies
- •Untreated brain metastases
- •Currently active (or history of) autoimmune disease
- •Taking the equivalent of >10 mg / day of prednisone
- •Taking a medication that moderately induces CYP2C, strongly inhibits CYP2C8, or interacts with both enzymes (CYP3A and CYP2C8)
- •Uncontrolled or clinically significant interstitial lung disease (ILD) / pneumonitis that requires systemic corticosteroid treatment or suspected ILD / pneumonitis
- •HIV infection, active hepatitis B or hepatitis C infection
研究组 & 干预措施
SBT6050 + T-DXd (5.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
干预措施: trastuzumab deruxtecan (Drug)
SBT6050 + T-DXd (6.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
干预措施: SBT6050 (Drug)
SBT6050 + T-DXd (5.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
干预措施: SBT6050 (Drug)
SBT6050 + T-DXd (6.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
干预措施: trastuzumab deruxtecan (Drug)
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
SBT6050 plus tucatinib, trastuzumab, and capecitabine
干预措施: SBT6050 (Drug)
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
SBT6050 plus tucatinib, trastuzumab, and capecitabine
干预措施: tucatinib (Drug)
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
SBT6050 plus tucatinib, trastuzumab, and capecitabine
干预措施: trastuzumab (Drug)
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
SBT6050 plus tucatinib, trastuzumab, and capecitabine
干预措施: capecitabine (Drug)
SBT6050 + Tucatinib + Trastuzumab
SBT6050 plus tucatinib and trastuzumab
干预措施: SBT6050 (Drug)
SBT6050 + Tucatinib + Trastuzumab
SBT6050 plus tucatinib and trastuzumab
干预措施: tucatinib (Drug)
SBT6050 + Tucatinib + Trastuzumab
SBT6050 plus tucatinib and trastuzumab
干预措施: trastuzumab (Drug)
结局指标
主要结局
Number of Participants With an Objective Response Rate
时间窗: 0 weeks
Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose expansion cohorts.
Proportion of Participants With Dose Limiting Toxicities
时间窗: 21 days
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.
Number of Participants With Treatment-emergent Adverse Events
时间窗: 18 weeks
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.
Number of Participants With Laboratory Abnormalities
时间窗: 18 weeks
Clinically significant treatment-emergent laboratory abnormalities as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.
次要结局
- Number of Participants With Treatment-emergent Adverse Events(0 weeks)
- Proportion of Participants With Clinical Benefit Rate(0 weeks)
- Duration of Response for Participants With an Objective Response Rate(0 weeks)
- Number of Participants With an Objective Response Rate(18 weeks)