OncoMatch/Clinical Trials/NCT07815522
Abiraterone With Dalpiciclib in Salivary Gland Carcinoma
Official title: A Prospective, Open-Label, Single-Arm, Phase II Clinical Study of Abiraterone Combined With Dalpiciclib in Patients With HER-2-Negative, AR-Positive Recurrent/Metastatic Salivary Gland Carcinoma
Is NCT07815522 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies abiraterone combined with dalpiciclib for salivary gland carcinoma.
Treatment: abiraterone combined with dalpiciclib — This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of abiraterone combined with dalpiciclib in recurrent/metastatic salivary gland carcinoma patients with AR positive and Her-2 negative. The participants would receive abiraterone combined with dalpiciclib until termination criteria are met.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
HER-2-negative and AR-positive status determined by immunohistochemistry (IHC)
Required: AR expression (positive)
HER-2-negative and AR-positive status determined by immunohistochemistry (IHC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: antiandrogen
prior exposure to anti-androgen therapy
Cannot have received: CDK4/6 inhibitor
prior exposure to ... CDK4/6 inhibitors
Lab requirements
Blood counts
haemoglobin ≥100 g/L, white blood cell count ≥4.0 × 10⁹/L or absolute neutrophil count ≥2.0 × 10⁹/L, platelet count ≥100 × 10⁹/L, in the absence of transfusion or colony-stimulating factor support
Kidney function
serum creatinine ≤1.5 × ULN OR creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L
Liver function
total serum bilirubin ≤1.5 × ULN; AST and ALT ≤1.5 × ULN
Cardiac function
no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency
Adequate major-organ function within 2 weeks prior to study treatment initiation, meeting the following criteria: Bone marrow: haemoglobin ≥100 g/L, white blood cell count ≥4.0 × 10⁹/L or absolute neutrophil count ≥2.0 × 10⁹/L, platelet count ≥100 × 10⁹/L, in the absence of transfusion or colony-stimulating factor support; Liver: total serum bilirubin ≤1.5 × ULN; AST and ALT ≤1.5 × ULN; Kidney: serum creatinine ≤1.5 × ULN OR creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L; Urine protein: negative; if urine protein is 1+, 24-hour total urinary protein must be <500 mg; Glucose: within normal range; or patients with diabetes with stable glycaemic control under ongoing management; Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07815522 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antiandrogen, CDK4/6 inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require AR?
Yes, AR expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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