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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients volunteered to participate in this study and signed informed consent; 2. Aged ≥ 18 but ≤ 75 years, male or female; 3. Histologically confirmed to be locally advanced or metastatic salivary gland carcinoma; 4. Arm1: salivary gland carcinoma patients with HER-2 alteration including HER-2 positive or mutation/amplification; 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 HER2 expression; 5. 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); 6. ECOG Perfomance Status: 0~1; 7. Estimated survival time ≥ 12 weeks; 8. 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); 9. 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; 10. 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.

Exclusion Criteria:

1. 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. 2. 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. 3. 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); 4. 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. 5. 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); 6. 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; 7.
Abnormal coagulation function (INR>1.5×ULN,activated partial thromboplastin time>1.5×ULN), with bleeding tendency.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05924256
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fudan University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dongmei Ji, Doctor
Principal Investigator Affiliation Fudan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Salivary Gland Carcinoma
Additional Details

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)

Arms & Interventions

Arms

Experimental: Arm 1

This arm for HER2-alteration salivray gland carcinoma.

Experimental: Arm 2

This arm for AR-postive salivray gland carcinoma.

Experimental: Arm 3

This arm for salivray gland carcinoma without HER-2 alteration or AR-postive.

Experimental: Arm 4

This arm for low HER2 expression salivray gland carcinoma.

Interventions

Drug: - SHR-A1811

SHR-A1811

Drug: - SHR 3680 + leuprolide

SHR 3680 + leuprolide

Drug: - SHR-A1921

SHR-A1921

Drug: - SHR-A1811

SHR-A1811

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Dongmei Ji, Shanghai, China

Status

Recruiting

Address

Dongmei Ji

Shanghai, ,

Site Contact

Dongmei Ji, Doctor

[email protected]

13564183928

Nearest Location

Site Contact

Dongmei Ji, Doctor

[email protected]

13564183928


Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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