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ADC and SBRT for Recurrent/Metastatic Salivary Gland Carcinoma

NCT07579598 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-12

No results posted yet for this study

Summary

This is a single-arm, single-center, exploratory clinical study. The study plans to enroll patients with recurrent or metastatic head and neck salivary gland carcinoma (HN-SGC) . The trial comprises two cohorts: Cohort 1 (adenoid cystic carcinoma, ACC) and Cohort 2 (non-ACC SGC). Patients in Cohort 1 will initially receive MRG003, an EGFR-targeted antibody-drug conjugate (ADC). Patients in Cohort 2 will initially receive either MRG003 (EGFR-ADC) or a TROP2-targeted ADC. The selection between these two ADC therapies for Cohort 2 will be determined by the investigator based on the expression levels of specific tumor surface receptors.

Tumor response will be assessed by imaging every 6 weeks (±7 days). Subjects who are assessed as having stable disease (SD) on two consecutive evaluations or who develop oligometastatic progression will receive stereotactic body radiation therapy (SBRT). Following SBRT, maintenance therapy with the original ADC will be continued.

Treatment discontinuation will be permitted due to disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other protocol-specified reasons, whichever occurs first. After treatment completion, all subjects will enter a post-treatment phase for safety visits and survival follow-up. For subjects who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted during the post-treatment period.

Conditions

  • Adenoid Cystic Carcinoma of the Head and Neck
  • SBRT
  • Antibody-drug Conjugates

Interventions

DRUG

Becotatug Vedotin

The initial dosage is 2.3 mg/kg, administered intravenously every three weeks per treatment cycle. A single dose reduction level (Level 1) to 2.0 mg/kg is permitted based on predefined criteria; the specific dose reduction scheme is detailed in the study protocol.

RADIATION

SBRT

The specific SBRT dose and fractionation will be determined based on the lesion site and prior history of radiation therapy. The standard dose range for SBRT will be 14 Gy-36 Gy, administered over 4-6 fractions (for example, 3.7 Gy per fractionfor 4 fractions). Adjustments to the dose and fractionation schedule maybe made according to individual patient needs and prior treatments.

DRUG

Becotatug Vedotin or Sacituzumab Tirumotecan

Becotatug Vedotin (MRG003): The initial dosage is 2.3 mg/kg, administered intravenously every three weeks per treatment cycle. A single dose reduction level (Level 1) to 2.0 mg/kg is permitted based on predefined criteria; the specific dose reduction scheme is detailed in the study protocol. Sacituzumab Tirumotecan (SKB264): The initial dosage is 5 mg/kg, administered intravenously every two weeks. A single dose reduction level (Level 1) to 4 mg/kg is permitted based on predefined criteria; the specific dose reduction scheme is detailed in the study protocol.

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-31
Completion
2027-12-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579598 on ClinicalTrials.gov