Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma

Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma: a Single-arm Phase 2 Trial

The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC).

The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years.

Study Overview

• Status: Recruiting
• Conditions: Salivary Gland Neoplasm Duct
• Intervention / Treatment: Drug: Rezvilutamide; Drug: Leuprolide Acetate

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Xueying Ren, MD; Phone Number: +86 10 83572408; Email: xy_ren1031@126.com
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University School and Hospital of Stomatology
      • Contact: Xiaofeng Shan, MD; Phone Number: +86 10 82195390; Email: kqsxf@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Histologically confirmed salivary duct carcinoma and stage III or IVa or IVb according to AJCC Cancer Staging Manual Eighth Edition
• Completed SDC surgery, and adjuvant radiotherapy is planned or ongoing or has completed
• Androgen receptor (AR) positive
• White blood cell (WBC) ≥ 3.0 x 10^9/L, Neutrophil count≥ 1.5 x 10^9/L, Platelet count (PLT) ≥ 75 x 10^9/L, Haemoglobin (Hb) ≥ 90 g/L
• Serum creatinine (Cr) < 1.5 x upper limit of normal(ULN) or creatinine clearance ≥ 50 ml/min.
• Total bilirubin (TBIL) < 1.5 x ULN, AST< 2.5 x ULN, and ALT< 2.5 x ULN
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, and ability to take oral medication
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 year after the end of study intervention administration
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

• Received prior anti-AR pathway therapy
• Treatment with another investigational drug or chemotherapy within 6 months
• History of hypothalamus or pituitary dysfunction
• History of seizure
• Clinically uncontrolled diseases, such as septic shock, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) class III or IV heart disease, clinically unstable arrhythmia, myocardial infarction (in the past 6 months)
• Previous cancer except skin cancer rather than malignant melanoma or any cancer curatively treated > 5 years prior to study entry
• Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rezvilutamide plus LHRHa; Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years.	Drug: Rezvilutamide; Rezvilutamide 240 mg (3*80mg tablets) will be administered orally once daily with or without food.; Drug: Leuprolide Acetate; The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease-free survival (DFS)	DFS is defined as the time from entry until disease recurrence or death	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival (OS)	OS is defined as the time from entry until death due to any cause	36 months, 60 months
3-year disease-specific survival (DSS)	DSS is defined as the time from entry until disease-specific death	36 months, 60 months
3-year distant-metastatic free survival (DMFS)	DMFS is defined as the time from entry until distant metastasis or death	36 months, 60 months
Adverse events	Evaluate adverse events utilizing CTCAE V5	36 months
5-year disease-free survival (DFS)	DFS is defined as the time from entry until disease recurrence or death	60 months

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.; Beijing Biote Pharmaceutical Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2031

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: March 30, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Salivary Gland Neoplasms; Carcinoma, Ductal; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropin-Releasing Hormone; Leuprolide
• Other Study ID Numbers: SDC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No