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Sac-TMT in Salivary Gland Cancers (Saint-Tropez)

2026年11月5日 更新者：Latin American Cooperative Oncology Group

Phase 2 Study of Sacituzumab Tirumotecan (Sac-TMT) in Salivary Gland Cancers - Saint-Tropez (LACOG 1824) Trial

This is a Phase 2, open-label, non-randomized, parallel, two-cohort study evaluating the efficacy and safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) monotherapy in patients with advanced, recurrent, or metastatic salivary gland carcinomas who have received no more than 3 prior non-curative systemic treatment regimens. The study evaluates the activity of Sac-TMT separately in two independent cohorts based on tumor histology: Cohort 1 for Adenoid Cystic Carcinoma (ACC) and Cohort 2 for Non-Adenoid Cystic Carcinoma (non-ACC).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Malignant salivary gland neoplasms are rare and heterogeneous malignancies with limited systemic treatment options and no widely established standard-of-care in advanced settings. Trophoblast cell surface antigen 2 (TROP-2) is broadly expressed in epithelial salivary gland carcinomas, making it a promising therapeutic target. Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2 coupled with a topoisomerase 1 inhibitor payload (KL610023).

This study aims to evaluate the clinical activity, safety, and patient-reported outcomes of Sac-TMT in two parallel, non-comparative cohorts:

Cohort 1: Patients with advanced/metastatic Adenoid Cystic Carcinoma (ACC). Cohort 2: Patients with advanced/metastatic Non-Adenoid Cystic Carcinoma (non-ACC).

Participants receive Sac-TMT at a dose of 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles (approximately 1 year), or until disease progression, unacceptable toxicity, or withdrawal of consent. The primary objective is to evaluate the Objective Response Rate (ORR) according to RECIST 1.1 in each cohort. Secondary objectives include assessment of ORR by Independent Central Review (ORR-ICR), Disease Control Rate (DCR), Duration of Response (DoR), Progression-Free Survival (PFS), 6- and 12-month PFS, Overall Survival (OS), safety and tolerability, compliance, post-progression therapies, and Patient-Reported Outcomes (EORTC QLQ-C30 and EORTC QLQ-H&N43). Exploratory research will assess ctDNA dynamics and potential predictive/resistance biomarkers in baseline and serial blood and tissue samples.

研究类型

介入性

注册 (估计的)

64

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 巴西
    • Ceará
      • Fortaleza、Ceará、巴西、60335-480
        • CRIO - Centro Regional Integrado de Oncologia
        • 接触：
        • 首席研究员：
          • Iane Pinto Figueiredo Lima
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、40050-410
        • Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
        • 首席研究员：
          • Daniel Brito
        • 接触：
    • Federal District
      • Brasília、Federal District、巴西、70710-904
        • CETTRO - Centro de Câncer de Brasília (Onco Vida - Oncoclínicas)
        • 接触：
        • 首席研究员：
          • Janice Rodrigues Farias
    • INCA - Instituto Nacional de Câncer
      • Rio de Janeiro、INCA - Instituto Nacional de Câncer、巴西、20230-130
        • INCA - Instituto Nacional de Câncer
        • 接触：
        • 首席研究员：
          • Daniel Gonçalves Kischinhevsky
    • Minas Gerais
      • Belo Horizonte、Minas Gerais、巴西、30360-680
        • Oncocentro de Minas Gerais (Oncoclínicas)
        • 接触：
        • 首席研究员：
          • Aline Lauda Freitas Chaves
    • Paraná
      • Londrina、Paraná、巴西、86015-520
        • HCL - Hospital do Câncer de Londrina
        • 接触：
        • 首席研究员：
          • Mariana Lopes Zanatta
    • Rio Grande do Norte
      • Natal、Rio Grande do Norte、巴西、59062-000
        • Liga Norte Riograndense Contra o Câncer
        • 接触：
        • 首席研究员：
          • Andrea Juliana Pereira de Santana Gomes
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90050-170
        • ISCMPA - Santa Casa de Porto Alegre
        • 接触：
        • 首席研究员：
          • Jamille Rizzardi Lava
    • Rio de Janeiro
      • Rio de Janeiro、Rio de Janeiro、巴西、22250-905
        • CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)
        • 接触：
        • 首席研究员：
          • Marina Xavier Reis
    • Santa Catarina
      • Lages、Santa Catarina、巴西、88501-001
        • ANIMI - Unidade de Tratamento Oncológico
        • 接触：
        • 首席研究员：
          • Maitê de Liz Vassen Schurmann
    • São Paulo
      • Barretos、São Paulo、巴西、14784-400
        • Hospital de Amor de Barretos
        • 接触：
        • 首席研究员：
          • Flávio Augusto Ferreira da Silva
      • Campinas、São Paulo、巴西、13083-881
        • Universidade Estadual de Campinas (UNICAMP)
        • 接触：
        • 首席研究员：
          • Lígia Traldi Macedo
      • São Paulo、São Paulo、巴西、01509-001
        • A.C. Camargo Cancer Center
        • 接触：
        • 首席研究员：
          • Thiago Bueno de Oliveira
      • São Paulo、São Paulo、巴西、01246-000
        • ICESP - Instituto do Câncer do Estado de São Paulo
        • 首席研究员：
          • Milena Perez Mak
        • 接触：
      • São Paulo、São Paulo、巴西、04538-135
        • CPO - Centro Paulista de Oncologia (Oncoclínicas)
        • 接触：
        • 首席研究员：
          • Nathalia Gimenes

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Provided written informed consent for the study (or prescreening phase, as applicable).

  2. Histologically- or cytologically confirmed diagnosis of malignant salivary gland neoplasm (assessed by central pathology):

    • Cohort 1: Adenoid cystic carcinoma (ACC) of the salivary gland.
    • Cohort 2: Non-adenoid cystic carcinoma (non-ACC) of the salivary gland.

  3. Advanced disease, defined as locally advanced or recurrent disease not amenable to curative treatment, and/or metastatic disease.

  4. Documented disease progression within 6 months prior to enrollment.

  5. Received no more than 3 prior lines of non-curative intent systemic treatment regimens. Note: Patients with salivary duct carcinoma must have been tested for HER2 status; if HER2 positive (IHC 3+ or gene amplified), prior HER2-targeted therapy is required.

  6. Measurable disease as defined by RECIST v1.1.

  7. Aged 18 years or older at the time of signing informed consent.

  8. ECOG Performance Status of 0 or 1.

  9. Adequate organ function within 14 days prior to treatment initiation:

    • Absolute Neutrophil Count (ANC) >= 1,500/uL;
    • Platelets >= 100,000/uL;
    • Hemoglobin >= 9.0 g/dL (without transfusion or growth factor support within 2 weeks);
    • Measured or calculated creatinine clearance >= 30 mL/min;
    • Total bilirubin <= 1.5 x ULN (or direct bilirubin < ULN for total bilirubin > 1.5 x ULN);
    • AST and ALT <= 2.5 x ULN (<= 5 x ULN if liver metastases present);
    • Serum albumin >= 3.0 g/dL (without albumin transfusion within 72 hours);
    • INR/PT/aPTT <= 1.5 x ULN (unless receiving therapeutic anticoagulation).

  10. Provision of archival FFPE tumor tissue sample or fresh biopsy.

  11. Recovery from adverse events due to prior anticancer therapies to Grade <= 1 or baseline.

  12. Participants with treated HIV, HBV, or HCV are eligible if meeting protocol-specified antiviral stability and disease control parameters.

  13. Adherence to protocol-specified contraceptive requirements for male participants and participants of childbearing potential.

Exclusion Criteria:

  1. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
  2. Uncontrolled or significant cardiovascular or cerebrovascular disease within 6 months prior to first dose (e.g., NYHA Class III/IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF > 480 ms).
  3. Prior treatment with a TROP2-targeted ADC or a topoisomerase 1 inhibitor-containing ADC.
  4. Systemic anticancer therapy within 2 weeks before the first dose of study intervention.
  5. Radiotherapy within 7 days before the first dose (except <= 10 fractions of palliative radiotherapy for non-CNS disease).
  6. Administration of a live or live-attenuated vaccine within 30 days before the first dose.
  7. Current use of strong CYP3A4 inducers or inhibitors requiring a 2-week washout prior to enrollment.
  8. Concurrent enrollment in another therapeutic clinical trial.
  9. Receipt of an investigational agent or device within 4 weeks before the first dose.
  10. History of additional active malignancy within the past 3 years (except adequately treated non-melanoma skin cancer, carcinoma in situ, or low-risk prostate cancer).
  11. Active, untreated, or unstable CNS metastases and/or carcinomatous meningitis.
  12. Active infection requiring systemic therapy.
  13. Severe hypersensitivity (Grade >= 3) to study intervention or its excipients.
  14. Major surgery or significant traumatic injury within 4 weeks before the first dose.
  15. History of noninfectious pneumonitis/ILD requiring steroids or current clinically meaningful pneumonitis/ILD.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1: Adenoid Cystic Carcinoma (ACC)

Participants with advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC) of the salivary gland who have received no more than three prior non-curative systemic treatment regimens. Participants receive Sacituzumab Tirumotecan (Sac-TMT) monotherapy at 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles, or until disease progression, unacceptable toxicity, or withdrawal of consent.
生物：Sacituzumab Tirumotecan (Sac-TMT)

Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2. Administered via intravenous (IV) infusion at a dose of 4 mg/kg on Days 1 and 15 of each 28-day cycle for up to 12 cycles.

其他名称：
  • MK-2870
实验性的：Cohort 2: Non-Adenoid Cystic Carcinoma (Non-ACC)

rticipants with advanced, recurrent, or metastatic non-adenoid cystic carcinoma (non-ACC) of the salivary gland who have received no more than three prior non-curative systemic treatment regimens. Participants receive Sacituzumab Tirumotecan (Sac-TMT) monotherapy at 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles, or until disease progression, unacceptable toxicity, or withdrawal of consent.
生物：Sacituzumab Tirumotecan (Sac-TMT)

Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2. Administered via intravenous (IV) infusion at a dose of 4 mg/kg on Days 1 and 15 of each 28-day cycle for up to 12 cycles.

其他名称：
  • MK-2870

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Objective Response Rate (ORR) in Cohort 1 (ACC)
大体时间：Up to 12 cycles (approximately 12 months).

Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 in the Adenoid Cystic Carcinoma cohort.
Up to 12 cycles (approximately 12 months).
Objective Response Rate (ORR) in Cohort 2 (Non-ACC)
大体时间：Up to 12 cycles (approximately 12 months).

Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 in the Non-Adenoid Cystic Carcinoma cohort.
Up to 12 cycles (approximately 12 months).

次要结果测量

结果测量
措施说明
大体时间
Objective Response Rate by Independent Central Review (ORR-ICR)
大体时间：From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).

Percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) as determined by an Independent Central Review (ICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
Disease Control Rate (DCR)
大体时间：From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).

Percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
Duration of Response (DoR)
大体时间：From first documented response until disease progression or death, assessed up to 40 months.

Time from the first documented objective response (complete response [CR] or partial response [PR]) to the date of first documented disease progression according to RECIST v1.1 or death due to any cause, evaluated in responders only.
From first documented response until disease progression or death, assessed up to 40 months.
Progression-Free Survival (PFS)
大体时间：From treatment initiation until disease progression or death, assessed up to 40 months.

Time from treatment initiation to first documented disease progression according to RECIST v1.1 (as evaluated by investigator assessment) or death due to any cause, whichever occurs first.
From treatment initiation until disease progression or death, assessed up to 40 months.
6-Month Progression-Free Survival (6-Month PFS)
大体时间：At 6 months.

Percentage of participants alive and progression-free at 6 months after enrollment according to RECIST v1.1, estimated using the Kaplan-Meier method.
At 6 months.
12-Month Progression-Free Survival (12-Month PFS)
大体时间：At 12 months.

Percentage of participants alive and progression-free at 12 months after enrollment according to RECIST v1.1, estimated using the Kaplan-Meier method.
At 12 months.
Overall Survival (OS)
大体时间：From treatment initiation until death, assessed up to 40 months.

Time from treatment initiation to death from any cause.
From treatment initiation until death, assessed up to 40 months.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：From baseline through 30 days after the last dose of study treatment (approximately 13 months).

Number of participants with treatment-emergent adverse events (TEAEs) of any grade and Grade 3 or higher, characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
From baseline through 30 days after the last dose of study treatment (approximately 13 months).
Change From Baseline in Health-Related Quality of Life Using EORTC QLQ-C30
大体时间：Baseline, every 6 weeks up to 24 weeks.

Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire includes functional scales, symptom scales, and a global health status/QoL scale. All domain and item scores are linearly transformed to a 0 to 100 scale. For functional scales and global health status, higher scores represent better quality of life and higher level of functioning. For symptom scales, higher scores represent greater symptom burden/severity.
Baseline, every 6 weeks up to 24 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Latin American Cooperative Oncology Group

调查人员

  • 首席研究员：William Nassib William Junior、CPO - Centro Paulista de Oncologia (Oncoclínicas)
  • 首席研究员：Aline Lauda Freitas Chaves、Oncocentro de Minas Gerais (Oncoclínicas)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月1日

初级完成 (估计的)

2030年4月1日

研究完成 (估计的)

2032年3月1日

研究注册日期

首次提交

2026年10月27日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LACOG 1824

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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