A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 81
- 主要终点
- Number of Participants Who Experience One or More Adverse Events (AEs)
研究概览
简要总结
Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.
The goals of this study are to learn:
- How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare
- About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •The main inclusion criteria include but are not limited to the following:
- •Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
- •Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- •Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
- •Has active infection, other than those permitted per protocol, requiring systemic therapy
- •Has not adequately recovered from major surgery or has ongoing surgical complications
研究组 & 干预措施
Calderasib + Cetuximab
Participants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
干预措施: Cetuximab (Biological)
Calderasib
Participants will receive calderasib orally. Per protocol treatment of calderasib has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
干预措施: Calderasib (Drug)
Calderasib + Cetuximab
Participants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
干预措施: Calderasib (Drug)
结局指标
主要结局
Number of Participants Who Experience One or More Adverse Events (AEs)
时间窗: Up to approximately 76 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.
Objective Response Rate (ORR)
时间窗: Up to approximately 76 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 76 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
次要结局
- Progression-free Survival (PFS)(Up to approximately 76 months)
- Duration of Response (DOR)(Up to approximately 76 months)
- Overall Survival (OS)(Up to approximately 76 months)