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

5. listopadu 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

64

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Biologický: 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.

Ostatní jména:
  • MK-2870
Experimentální: 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.
Biologický: 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.

Ostatní jména:
  • MK-2870

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective Response Rate (ORR) in Cohort 1 (ACC)
Časové okno: 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)
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective Response Rate by Independent Central Review (ORR-ICR)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Latin American Cooperative Oncology Group

Vyšetřovatelé

  • Vrchní vyšetřovatel: William Nassib William Junior, CPO - Centro Paulista de Oncologia (Oncoclínicas)
  • Vrchní vyšetřovatel: Aline Lauda Freitas Chaves, Oncocentro de Minas Gerais (Oncoclínicas)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. března 2027

Primární dokončení (Odhadovaný)

1. dubna 2030

Dokončení studie (Odhadovaný)

1. března 2032

Termíny zápisu do studia

První předloženo

27. října 2026

První předloženo, které splnilo kritéria kontroly kvality

5. listopadu 2026

První zveřejněno (Aktuální)

10. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • LACOG 1824

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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