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

NCT06348264 | Recruiting Phase 2

• 1 other identifier: SDC-1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Salivary Gland Neoplasm Duct

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival (DFS)

  DFS is defined as the time from entry until disease recurrence or death

  36 months

Secondary Outcomes (5)

• 3-year overall survival (OS)

  36 months, 60 months

• 3-year disease-specific survival (DSS)

  36 months, 60 months

• 3-year distant-metastatic free survival (DMFS)

  36 months, 60 months

• Adverse events

  36 months

• 5-year disease-free survival (DFS)

  60 months

Study Arms (1)

Rezvilutamide plus LHRHa

EXPERIMENTAL

Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years.

Drug: Rezvilutamide; Drug: Leuprolide Acetate

Interventions

Rezvilutamide DRUG

Rezvilutamide 240 mg (3\*80mg tablets) will be administered orally once daily with or without food.

Rezvilutamide plus LHRHa

Leuprolide Acetate DRUG

The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.

Rezvilutamide plus LHRHa

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator
• Beijing Biote Pharmaceutical Co.,Ltd: collaborator

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Leuprolide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 4, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2031
• Last Updated: September 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)