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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).

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

64

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
生物学的：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.

他の名前：
  • MK-2870
実験的：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.
生物学的：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.

他の名前：
  • MK-2870

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) in Cohort 1 (ACC)
時間枠：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)
時間枠：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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate by Independent Central Review (ORR-ICR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Latin American Cooperative Oncology Group

捜査官

  • 主任研究者：William Nassib William Junior、CPO - Centro Paulista de Oncologia (Oncoclínicas)
  • 主任研究者：Aline Lauda Freitas Chaves、Oncocentro de Minas Gerais (Oncoclínicas)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年3月1日

一次修了 (推定)

2030年4月1日

研究の完了 (推定)

2032年3月1日

試験登録日

最初に提出

2026年10月27日

QC基準を満たした最初の提出物

2026年11月5日

最初の投稿 (実際)

2026年11月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月10日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • LACOG 1824

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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