SENTINEL-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors That Harbor the KRas G12V Mutation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Part A Monotherapy Dose Escalation
研究概览
简要总结
Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
详细描述
CLSP-5282-101 is a Phase 1, open-label, multicenter study designed to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP-5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
The study will be conducted in 2 parts:
Part A Monotherapy Dose Escalation to determine the MTD and/or RDE(s) to characterize safety and clinical activity of CLSP-5282.
Part B Monotherapy Expansion to explore the preliminary antitumor activity and further characterize the safety, tolerability, PK, and PD of CLSP-5282 at the RDE(s). Part B will include three indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Adults at least 18 years of age on the day of signing informed consent.
- •Willing and able to provide written informed consent for the study.
- •Histologically or cytologically diagnosed, locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.
- •Tumors must harbor the KRas G12V mutation confirmed by the site's local or preferred tissue or ctDNA testing platform in an accredited laboratory.
- •Patients must be HLA-A*03:01 positive by central assay.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •Adequate hematological, renal and hepatic function.
- •Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation.
排除标准
- •Patients who have received other KRas G12V directed cellular therapies or TCEs.
- •Patients may not be on other anticancer therapies at the time of the first dose of CLSP-
- •Exceptions upon agreement with Sponsor.
- •Any other primary malignancy within the 2 years prior to first dose of study treatment except for non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or prostate cancer in remission.
- •Patients who have not fully recovered from adverse events due to previous anticancer therapies
- •Patients with active infection requiring systemic antimicrobial therapy
- •Known primary malignant brain tumors, active central nervous system metastases and/or carcinomatous meningitis
研究组 & 干预措施
Part A Monotherapy Dose Escalation
Dose Escalation of CLSP-5282 in HLA A*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
干预措施: CLSP-5282 (Drug)
Part B Monotherapy Expansion
Dose expansion of CLSP-5282 in indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort conducted at the RDE.
干预措施: CLSP-5282 (Drug)
结局指标
主要结局
Part A Monotherapy Dose Escalation
时间窗: 28 days after infusion
To characterize the safety and tolerability of CLSP-5282 and to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE\[s\]).
Part B Monotherapy Expansion
时间窗: Up to 24 months after infusion
To evaluate the preliminary antitumor activity of CLSP-5282
次要结局
- Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0(Up to 30 days after last infusion)
- Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0(Up to 30 days after last infusion)
- Determine Maximum Plasma Concentration of CLSP-5282(Pre-dose and up to 168 hours post-dose)
- Half-life (t1/2) of CLSP-5282(Pre-dose and up to 168 hours post-dose)
- Assess the immunogenicity of CLSP-5282(Up to 24 months after infusion)
- Part A: Objective Response Rate (ORR)(Up to 24 months after infusion)
- Duration of response (DOR)(Up to 24 months after infusion)
- Time to Response(Up to 24 months after infusion)
- Disease Control Rate(Up to 24 months after infusion)
- Progression-free survival (PFS)(Up to 24 months after infusion)
- Time on Treatment(Up to 24 months after infusion)
- Overall Survival (OS)(Up to 24 months after infusion)