Abiraterone With Dalpiciclib in Salivary Gland Carcinoma

NCT07815522 | Recruiting Phase 2

• 1 other identifier: SH9H-2026-1439-3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Salivary Gland Carcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate

  ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

  12 months

Secondary Outcomes (3)

• Progression Free Survival

  12 months

• overall survival

  12 months

• Number of Participants Experiencing an Adverse Event (AE)

  12 months

Study Arms (1)

abiraterone combined with dalpiciclib

EXPERIMENTAL

The dosing regimen for abiraterone combined with dalpiciclib is as follows: abiraterone is administered orally at 1 g once daily, in combination with prednisone 5 mg orally twice daily. The recommended dose of dalpiciclib is 150 mg once daily for 21 consecutive days, followed by a 7-day treatment break (3-on/1-off schedule), constituting a 28-day treatment cycle. Study subjects should take the medication at approximately the same time each day. Subjects will continue abiraterone plus dalpiciclib treatment until discontinuation criteria are met.

Drug: abiraterone combined with dalpiciclib

Interventions

abiraterone combined with dalpiciclib DRUG

The dosing regimen for abiraterone combined with dalpiciclib isethionate is as follows: abiraterone is administered orally at 1 g once daily, in combination with prednisone 5 mg orally twice daily. The recommended dose of dalpiciclib isethionate is 150 mg once daily for 21 consecutive days, followed by a 7-day treatment break (3-on/1-off schedule), constituting a 28-day treatment cycle. Study subjects should take the medication at approximately the same time each day. Subjects will continue abiraterone plus dalpiciclib isethionate treatment until discontinuation criteria are met.

abiraterone combined with dalpiciclib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Aged 18-75 years, male or female;
• Patients with histopathologically confirmed salivary gland malignancy of the head and neck: recurrent/metastatic disease without curative-intent therapeutic options (surgery/radiotherapy), or unresectable locally-advanced disease, with at least one measurable lesion (≥10 mm on spiral CT, complying with RECIST version 1.1);
• HER-2-negative and AR-positive status determined by immunohistochemistry (IHC);
• Availability of evaluable tumor tissue (paraffin-embedded specimen obtained within the past 2 years or fresh tumor tissue);
• ECOG performance status of 0 or 1;
• Expected survival ≥12 weeks;
• 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 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (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;
• For women of child-bearing potential: negative serum pregnancy test within 7 days before the first dose of study drug. Men with reproductive potential and women at risk of pregnancy must use highly-effective contraceptive measures throughout the study (e.g., oral contraceptives, intrauterine device, sexual abstinence, or barrier contraception combined with spermicide), and continue contraception for 12 months after treatment completion;
• Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and are willing to complete follow-up assessments;

You may not qualify if:

• \- Patients with prior exposure to anti-androgen therapy or CDK4/6 inhibitors.
• Patients receiving ongoing anti-neoplastic treatment.
• Patients who have participated in, or are participating in, another investigational drug/therapy clinical trial within 4 weeks prior to the first dose of study drug.
• Patients who received haematopoietic stimulating factors, such as granulocyte-colony-stimulating factor (G-CSF) or erythropoietin, within 1 week before the first administration of study drug.
• Positive serology for human immunodeficiency virus (HIV) antibody or \*Treponema pallidum\* antibody.
• Patients with active hepatitis B or hepatitis C:
• HBsAg-positive or HBcAb-positive subjects with detectable HBV DNA (value above the upper limit of normal);
• Subjects with positive HCV antibody and detectable HCV RNA (value above the upper limit of normal).
• Symptomatic and clinically significant pleural effusion or ascites requiring therapeutic intervention.
• Active pulmonary disease (interstitial pneumonia, pneumonitis, obstructive pulmonary disease, asthma) or history of active pulmonary tuberculosis.
• Presence of any uncontrolled clinical conditions, including but not limited to:
• Persistent or active (severe) infection;
• Poorly-controlled diabetes mellitus;
• Cardiac disease (New York Heart Association (NYHA) class III/IV congestive heart failure or cardiac conduction block).
• Occurrence of any of the following events within 6 months prior to first-dose administration: deep-vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischaemic attack, cerebral embolism.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

dalpiciclib

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Study Officials

• Yue He, M.D.

  the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoxin Ren, M.D.

CONTACT

13916948812; renguoxincn@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 11, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

CN (1)