Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of MK-2010 in Combination With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced may mean the cancer has spread to nearby or other parts of the body. The cancer may not be able to be treated with surgery or radiation, which uses beams of intense energy (like X-rays) to shrink or get rid of tumors. Some cancers may not have gone away or came back after previous treatment. MK-2010, the trial treatment, is designed to help the immune system fight cancer.
This trial will look at MK-2010 when given with another trial treatment called sacituzumab tirumotecan (sac-TMT). Sac-TMT is an antibody-drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The goals of this trial are to learn:
- About the safety of MK-2010 with sac-TMT and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.
- How many participants who receive MK-2010 with sac-TMT have the cancer respond to treatment. Respond means the cancer gets smaller or goes away.
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
- •Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)
- •If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks
- •If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
- •Has adequate organ function
排除标准
- •If prior anticancer therapy is allowed, participants are excluded if they received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before allocation
- •Has received prior locoregional therapy within 2 weeks of start of study intervention, or has ongoing locoregional treatment-related toxicities
- •Is currently receiving any anticoagulants
- •Was discontinued from prior immunotherapy due to a Grade ≥3 immune-related adverse event (irAE)
- •Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- •Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has active autoimmune disease that has required systemic treatment in the past 2 years
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
- •Active or ongoing stomatitis and/or mucositis of any grade
- •HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis
- •Has history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder
- •Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- •Has history of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or from central venous access device placement, or has ongoing surgical complications
- •Has clinically significant hemoptysis, hematemesis, or tumor bleeding within 4 weeks before the first dose of study intervention
- •Has any clinically significant or life-threatening bleeding event that occurred within 3 months prior to the first dose of the study intervention
- •Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
- •Has any history of myocarditis or cardiomyopathy
- •Has a current or history of severe cardiovascular and cerebrovascular diseases
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 27 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Part 1 Only)
时间窗: Up to approximately 28 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.
Number of Participants Who Discontinued Study Intervention Due to an AE
时间窗: Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Objective Response Rate (ORR)
时间窗: Up to approximately 60 months
ORR is defined as a confirmed 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, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
次要结局
- Incidence of Antidrug Antibodies (ADA) to MK-2010(Predose and at designated time points post-dose (up to approximately 24 months))
- Duration of Response (DOR)(Up to approximately 60 months)
- Area Under the Concentration-Time Curve (AUC) of MK-2010(Predose and at designated time points post-dose (up to approximately 24 months))
- Trough Concentration (Ctrough) of MK-2010(Predose and at designated time points post-dose (up to approximately 24 months))
- Maximum Plasma Concentration (Cmax) of MK-2010(Predose and at designated time points post-dose (up to approximately 24 months))