Aún no reclutaNCT07928193Registro de ClinicalTrials.gov

Sac-TMT in Salivary Gland Cancers

Salivary Gland Cancers · Adenoid Cystic Carcinoma of the Salivary Gland

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 64 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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).

Leer la descripción completa

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.

¿Quién podría participar?

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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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación: Sin asignación al azar
Enmascaramiento: Sin enmascaramiento

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.

Biological: Sacituzumab Tirumotecan (Sac-TMT)

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.

Biological: Sacituzumab Tirumotecan (Sac-TMT)

Sacituzumab Tirumotecan (Sac-TMT) BIOLOGICAL

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Objective Response Rate (ORR) in Cohort 1 (ACC)

Plazo: 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.

Objective Response Rate (ORR) in Cohort 2 (Non-ACC)

Plazo: 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.

Medidas secundarias

Objective Response Rate by Independent Central Review (ORR-ICR)

Plazo: 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).

Disease Control Rate (DCR)

Plazo: 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).

Duration of Response (DoR)

Plazo: 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.

Progression-Free Survival (PFS)

Plazo: 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.

6-Month Progression-Free Survival (6-Month PFS)

Plazo: 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.

12-Month Progression-Free Survival (12-Month PFS)

Plazo: 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.

Overall Survival (OS)

Plazo: From treatment initiation until death, assessed up to 40 months.

Time from treatment initiation to death from any cause.

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Plazo: 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).

Change From Baseline in Health-Related Quality of Life Using EORTC QLQ-C30

Plazo: 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.

El registro no indica resultados publicados.

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Centros de investigación (15)

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Buscar un centro en este estudio

15 centros

CRIO - Centro Regional Integrado de OncologiaFortaleza, Ceará, BrazilEstado desconocido

Amanda Lima SenaCONTACTtarcilo.crio@gmail.com

Iane Pinto Figueiredo LimaPRINCIPAL_INVESTIGATOR

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (15)

Equipo y fechas

Contactos oficiales del estudio

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