Active — Not RecruitingPhase 2

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

China88 participantsStarted 2023-07-26

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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;
✓. 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):

Exclusion criteria

✕. 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:
✕. 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.

What they're measuring

ORR

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

Trial details

NCT IDNCT05924256

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Advanced Salivary Gland Carcinoma trials