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

5. november 2026 opdateret af: 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

64

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: 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.

Andre navne:
  • MK-2870
Eksperimentel: 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.
Biologisk: 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.

Andre navne:
  • MK-2870

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR) in Cohort 1 (ACC)
Tidsramme: 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)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate by Independent Central Review (ORR-ICR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Latin American Cooperative Oncology Group

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. marts 2027

Primær færdiggørelse (Anslået)

1. april 2030

Studieafslutning (Anslået)

1. marts 2032

Datoer for studieregistrering

Først indsendt

27. oktober 2026

Først indsendt, der opfyldte QC-kriterier

5. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LACOG 1824

Plan for individuelle deltagerdata (IPD)

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