Adenoid Cystic Carcinoma of the Head and NeckPhase 2NCT07579598
ADC and SBRT for Recurrent/Metastatic Salivary Gland Carcinoma
A Phase 2 study testing Becotatug Vedotin, SBRT and Becotatug Vedotin or Sacituzumab Tirumotecan in people with Adenoid Cystic Carcinoma of the Head and Neck and SBRT, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenoid Cystic Carcinoma of the Head and Neck, SBRT, Antibody-drug Conjugates
- What is being tested?
- Becotatug Vedotin, SBRT and Becotatug Vedotin or Sacituzumab Tirumotecan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 12 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to the initiation of any study-specific procedures.
- Male or female patients aged 18-80 years.
- Histologically or cytologically confirmed head and neck squamous cell carcinoma or adenoid cystic carcinoma, expressing ADC-related targets (e.g., EGFR, TROP2), with evidence of recurrence and/or metastasis.
- Patients must have experienced disease progression after first-line standard therapy or be deemed unsuitable for such therapy, and meet the following conditions: (1) For adenoid cystic carcinoma, first-line treatment should include anti-angiogenic agents (e.g., TKIs or monoclonal antibodies), chemotherapy, or patients are considered unsuitable for standard first-line therapy by the investigator (e.g., high bleeding risk, non-healing wounds); (2) For other salivary gland carcinomas, patients must have progressed after first-line standard therapy or be unsuitable for such therapy.
- At least one measurable lesion according to RECIST version 1.1 based on imaging.
- Life expectancy of at least 6 months.
- ECOG performance status (PS) score of 0-1.
- Adequate organ function, defined by the following laboratory criteria: (1) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L without use of granulocyte colony-stimulating factor within 14 days prior to testing; (2) Platelet count ≥ 90 × 10⁹/L without transfusion within 14 days prior to testing; (3) Hemoglobin > 9 g/dL without transfusion or erythropoietin use within 14 days prior to testing; (4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; (6) Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); (7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Patients with abnormal baseline TSH may still be eligible if total T3 (or FT3) and FT4 are within normal limits; (9) Myocardial enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable); (10) Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1 Day 1). If a urine test result is inconclusive, a serum test is required. Women of non-childbearing potential are defined as those who are postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; (11) Willingness and ability to comply with study procedures, including treatment, contraceptive measures, scheduled visits, and follow-up assessments.
Who cannot join
- Diagnosis of malignancies other than head and neck tumors within 5 years prior to the first dose (except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following curative resection).
- Participation in another interventional clinical study or receipt of investigational drugs/devices within 4 weeks prior to the first dose.
- Prior treatment with ADC agents.
- Treatment of traditional Chinese medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; except for local use for pleural effusion control) within 2 weeks prior to the first dose.
- Known hypersensitivity to the active ingredients or excipients of the study drug.
- Failure to recover from toxicities and/or complications caused by prior interventions to ≤ Grade 1 or baseline (excluding fatigue or alopecia) prior to treatment initiation.
Show all 11Show fewer
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1/2 antibody positive).
- Untreated active hepatitis B infection (defined as HBsAg positive with HBV-DNA levels above the upper limit of normal for the study center laboratory). Note: Patients with hepatitis B may still be eligible if: (1) HBV viral load < 2.5 × 10³ copies/mL (500 IU/mL) prior to first dosing, and patients receive anti-HBV therapy throughout the study; (2) Patients with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load do not require prophylactic anti-HBV therapy but must be closely monitored for viral reactivation.
- Active hepatitis C infection (HCV antibody positive with HCV-RNA above the lower limit of detection).
- Pregnant or breastfeeding women.
- Presence of any severe or uncontrolled systemic disease, including but not limited to: (1) Significant and symptomatic abnormalities in cardiac rhythm, conduction, or morphology on resting ECG that are difficult to control, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation; (2) Unstable angina, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) class ≥ II; (3) Any arterial thrombosis, embolism, or ischemic event within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack); (4) Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to the first dose, or presence of unhealed wounds, ulcers, or fractures. Tissue biopsy or minor surgical procedures within 7 days prior to first dosing are also exclusionary, except for venous catheter placement for infusion; (5) Poorly controlled hypertension (systolic >140 mmHg and/or diastolic >90 mmHg); (6) Active pulmonary tuberculosis; (7) Active or uncontrolled infections requiring systemic therapy; (8) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; (9) Liver diseases such as cirrhosis, decompensated liver disease, or acute/chronic active hepatitis; (10) Poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L); (11) Proteinuria ≥ ++ on urinalysis confirmed by 24-hour urinary protein >1.0 g; (12) Psychiatric disorders that interfere with treatment compliance; (13) Any medical history, disease condition, treatment, or laboratory abnormality that may interfere with study results or the patient's full participation, or any other condition deemed unsuitable for enrollment by the investigator.
About this study
Official title: Antibody-Drug Conjugate Plus Stereotactic Body Radiotherapy in Recurrent or Metastatic Salivary Gland Carcinoma - A Phase II Exploratory Study
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.
- Being tested
- Becotatug Vedotin, SBRT, Becotatug Vedotin or Sacituzumab Tirumotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
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.
SBRTRadiation
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.
Becotatug Vedotin or Sacituzumab TirumotecanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (ACC) | Experimental | patients with R/M adenoid cystic carcinoma Receives: Drug: Becotatug Vedotin; Radiation: SBRT |
| Cohort 2 (non-ACC SGC) | Experimental | non-ACC head and neck salivary gland carcinoma Receives: Radiation: SBRT; Drug: Becotatug Vedotin or Sacituzumab Tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
the proportion of patients with a reduction in tumor volume of a predefined amount and for a minimum time period, including complete response (CR) and partial response (PR) cases
Measured: 1-year
Secondary outcomes (6)
Time to Response (TTR)
the interval from the date of treatmentinitiation (typically the first dose) to the date of the firstdocumented objective response (complete response [CR] or partial response [PR]).
- TTR1 (Onset of response to ADC): Defined as the time from initiationof antibody-drug conjugate (ADC) therapy to the first occurrence of an objective response(PR or CR). This metric reflects the initial onset of action of the ADC, whether administeredas monotherapy or as part of a combination regimen.
- TTR2(Onset of response to the overall combination therapy): Defined as the time from initiation of the fullcombination treatment regimen (i.e., after receivingADC therapy and completing the first course of SBRT) to the first occurrence of an objective response. This endpoint evaluates the onset of efficacy ofthe combination therapy as an integrated treatment approach.
Measured: 1-year
Disease Disease Control Rate (DCR)
Proportion of patients with a best overall response of confirmed CR, PR, or SD (SD must be confirmed at least 4 weeks after initial documentation).
Measured: 1-year
Progression-Free Survival (PFS)
Time from first treatment to disease progression or death from any cause, whichever occurs first.
Measured: 1-year
Overall Survival (OS)
Time from first treatment to death from any cause.
Measured: 1-year
Duration of Response (DOR)
Time from first documented objective response to disease progression or death, in patients with a confirmed objective response.
Measured: 1-year
Adverse Events (AEs)
Including type, incidence, severity (graded per NCI-CTCAE v5.0), duration, and relationship to study drugs.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579598
- Sponsor's protocol ID
- 2026HN-SGC
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody-Drug Conjugate Plus Stereotactic Body Radiotherapy in Recurrent or Metastatic Salivary Gland Carcinoma - A Phase II Exploratory Study
- ClinicalTrials.gov ID
- NCT07579598
- Acronym / sponsor ID
- 2026HN-SGC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (ACC) | Experimental | Drug: Becotatug Vedotin, Radiation: SBRTpatients with R/M adenoid cystic carcinoma |
| Cohort 2 (non-ACC SGC) | Experimental | Radiation: SBRT, Drug: Becotatug Vedotin or Sacituzumab Tirumotecannon-ACC head and neck salivary gland carcinoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent prior to the initiation of any study-specific procedures.
- Male or female patients aged 18-80 years.
- Histologically or cytologically confirmed head and neck squamous cell carcinoma or adenoid cystic carcinoma, expressing ADC-related targets (e.g., EGFR, TROP2), with evidence of recurrence and/or metastasis.
- Patients must have experienced disease progression after first-line standard therapy or be deemed unsuitable for such therapy, and meet the following conditions: (1) For adenoid cystic carcinoma, first-line treatment should include anti-angiogenic agents (e.g., TKIs or monoclonal antibodies), chemotherapy, or patients are considered unsuitable for standard first-line therapy by the investigator (e.g., high bleeding risk, non-healing wounds); (2) For other salivary gland carcinomas, patients must have progressed after first-line standard therapy or be unsuitable for such therapy.
- At least one measurable lesion according to RECIST version 1.1 based on imaging.
Key exclusion criteria (11 listed)
- Diagnosis of malignancies other than head and neck tumors within 5 years prior to the first dose (except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following curative resection).
- Participation in another interventional clinical study or receipt of investigational drugs/devices within 4 weeks prior to the first dose.
- Prior treatment with ADC agents.
- Treatment of traditional Chinese medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; except for local use for pleural effusion control) within 2 weeks prior to the first dose.
- Known hypersensitivity to the active ingredients or excipients of the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug VedotinThe 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. | Drug | Cohort 1 (ACC) |
| SBRTThe 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. | Radiation | Cohort 1 (ACC), Cohort 2 (non-ACC SGC) |
| Becotatug Vedotin or Sacituzumab TirumotecanBecotatug 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. | Drug | Cohort 2 (non-ACC SGC) |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1-year
the proportion of patients with a reduction in tumor volume of a predefined amount and for a minimum time period, including complete response (CR) and partial response (PR) cases
6 secondary outcomes
Time to Response (TTR)
Time frame: 1-year
Disease Disease Control Rate (DCR)
Time frame: 1-year
Progression-Free Survival (PFS)
Time frame: 1-year
Overall Survival (OS)
Time frame: 1-year
Duration of Response (DOR)
Time frame: 1-year
Adverse Events (AEs)
Time frame: 2-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin, SBRT and Becotatug Vedotin or Sacituzumab Tirumotecan in people with Adenoid Cystic Carcinoma of the Head and Neck and SBRT, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.