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Advanced Salivary Gland CarcinomaPhase 2NCT05924256

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing

A Phase 2 study testing SHR-A1811, SHR 3680 + leuprolide and SHR-A1921 in people with Advanced Salivary Gland Carcinoma, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-center, open-label, phase 2 study to evaluate the efficacy and safety of target therapy for patients with relapsed/metastastic salivary gland carcinoma based on molecular typing. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Salivary Gland Carcinoma
What is being tested?
SHR-A1811, SHR 3680 + leuprolide and SHR-A1921
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
26 Jul 2023to 30 Dec 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients volunteered to participate in this study and signed informed consent;
  • Aged ≥ 18 but ≤ 75 years, male or female;
  • Histologically confirmed to be locally advanced or metastatic salivary gland carcinoma;
  • Arm1: salivary gland carcinoma patients with HER-2 overexpression ； Arm 2: salivary gland carcinoma patients with AR-positive; Arm 3: salivary gland carcinoma patients without HER-2 alteration or AR-positive; Arm 4: salivary gland carcinoma patients with low HER-2 expression;
  • At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);
  • ECOG Perfomance Status: 0~1;
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  • Estimated survival time ≥ 12 weeks;
  • The main organs function are normal, and meet the following requirements (within 7 days before the start of study treatment):
  • Blood routine examination(no blood transfusion within 14 days before screening, no granulocyte colony stimulating factor (G-CSF), no medication corrected):1) Hemoglobin (HB)≥ 90g / L;2) Neutrophil count (ANC) ≥ 1.5 × 109 / L;3) platelets (PLT) ≥ 80 × 109 / L; Blood biochemical tests are subject to the following criteria (no albumin is delivered 14 days prior to screening):1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST])< 2.5 × ULN; if liver metastasis, ALT and AST ≤ 5 × ULN;3) Serum creatinine (Cr) ≤ 1 × ULN or endogenous creatinine clearance > 50ml / min (Cockcroft-Gault formula); International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the range of normal controls ≤ 6 seconds; Urine protein <2+ (if urine protein ≥ 2+, 24-hour urine protein can be quantified, 24-hour urine protein quantitation <1.0g can be included);
  • Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and volunteer to use appropriate methods during the observation period and within 8 weeks after the last study drug administration; for men, sterilization surgery should be performed, or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug;
  • Patient who are expected to have good compliance and can accept follow-up visit for the efficacy and adverse reactions according to the program requirements.

Who cannot join

  • Have other active malignancies within 5 years or at the same time. Localized tumors that have been cured, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled.
  • Other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, etc.) were used within 28 days prior to the first use of the study drug. if the last dose of anti-tumor drug had been stopped ≥ 5 half-life can be allowed.
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as:
  • According to the New York Heart Association (NYHA) standard, level II or higher cardiac dysfunction or echocardiography: left ventricular ejection fraction<50%; unstable angina; Myocardial infarction occurred within 1 year before the start of treatment; Clinically significant supraventricular or ventricular arrhythmia that requires treatment or intervention; corrected QT interval(QTc) > 450ms (male); QTc > 470ms (female) (Calculation of QTc interval with Fridericia formula; if the QTc is abnormal, it can be detected three times at an interval of 2 minutes, and the average value is taken);
  • Patients with high blood pressure who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (average of BP based on ≥2 measurements), allowing the use of antihypertensive treatment to achieve the above parameters.
  • A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction) (Only apply for Arm 2 patients);
  • Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) those with a history of melena and hematemesis within 3 months;
  • Abnormal coagulation function (INR>1.5×ULN,activated partial thromboplastin time>1.5×ULN), with bleeding tendency.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Dongmei Ji

    Shanghai

Other trials in China

About this study

This is a single-center, open-label, phase 2 study to evaluate the efficacy and safety of target therapy for patients with relapsed/metastastic salivary gland carcinoma based on molecular typing.

Read the detailed description

Patients with IHC HER2 IHC 3+ or IHC 2+/ISH+ will be located into arm 1 to receive anti-her2 ADC（SHR- A1811） Patients with IHC AR positive will be located into arm 2 to receive anti-androgen therapy (SHR-3680)+leuprolide Patients with HER2 negative and AR negative will be located into arm 3 to receive anti-TROP2 ADC (SHR-A1921) Patients with IHC HER2 IHC 1+ or IHC 2+/ISH- will be located into arm 4 to receive anti-her2 ADC（SHR- A1811）

Being tested
SHR-A1811, SHR 3680 + leuprolide, SHR-A1921

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A1811Drug

    SHR-A1811

  • SHR 3680 + leuprolideDrug

    SHR 3680 + leuprolide

  • SHR-A1921Drug

    SHR-A1921

  • SHR-A1811Drug

    SHR-A1811

Study groups in NCT05924256
Study groupRoleWhat they receive
Arm 1ExperimentalThis arm for HER2-positive salivray gland carcinoma.
Receives: Drug: SHR-A1811
Arm 2ExperimentalThis arm for AR-postive salivray gland carcinoma.
Receives: Drug: SHR 3680 + leuprolide
Arm 3： 3a adenoid cystic carcinoma and 3b non-adenoid cystic carcinomaExperimentalThis arm for salivray gland carcinoma without HER-2 alteration or AR-postive.
Receives: Drug: SHR-A1921
Arm 4ExperimentalThis arm for low HER2 expression salivray gland carcinoma.
Receives: Drug: SHR-A1811

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.

    Measured: at the end of every 2 cycles(for arm1, arm3 and arm4, each cycle is 21 days, for arm2, each cycle is 28 days)

Secondary outcomes (4)

  1. DCR

    DCR defined as the patients confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.

    Measured: at the end of every 2 cycles(for arm1, arm3 and arm4, each cycle is 21 days, for arm2, each cycle is 28 days)

  2. Progression-free Survival (PFS)

    Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: up to 2 years

  3. Overall Survival (OS)

    Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.

    Measured: up to 2 years

  4. Adverse events

    Hematologic and non hematologic adverse event (CTCAE 5.0）

    Measured: Since the signing of informed consent forms to 30 days after the last cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2023
  2. Study start26 Jul 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05924256
Sponsor's protocol ID
SGC-IIT-umbrella
Status last verified
Mar 2026
First submitted
21 Jun 2023
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen GL, Guo Y, Liu X, Yang Y, Sang Y, Lu X, Sun S, Shi X, Zhang Y, Chen TZ, Qu N, Wen D, Niu XS, Dong S, Wang Y, Wang Y, Wang J, Zhang L, Hu C, Ji Q, Ji D. Biomarker-Stratified Phase II Trial of Trastuzumab Rezetecan in Advanced Salivary Gland Carcinoma Across Cohorts With High and Low Human Epidermal Growth Factor Receptor 2 Expression. J Clin Oncol. 2026 Sep 20;44(27):2614-2624. doi: 10.1200/JCO-26-00671. Epub 2026 Aug 11.

    PubMed 42579830

  • Chen GL, Guo Y, Yang Y, Sang Y, Sun S, Liu X, Zhou X, Sheng CY, He X, Wang J, Shi R, Wang Y, Ji Q, Ji D. A Phase II study of SHR-A1921, a TROP2-targeted antibody-drug conjugate, in patients with recurrent or metastatic salivary gland carcinoma. NPJ Precis Oncol. 2026 May 13. doi: 10.1038/s41698-026-01463-5. Online ahead of print.

    PubMed 42129335

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A1811, SHR 3680 + leuprolide and SHR-A1921 in people with Advanced Salivary Gland Carcinoma, run by Fudan University at 1 site in China.

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 11 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

ORR (time frame: at the end of every 2 cycles(for arm1, arm3 and arm4, each cycle is 21 days, for arm2, each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05924256, which also lists 2 linked publications.

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 2 Apr 2026.

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