A targeted AR-directed therapy for advanced salivary gland cancer using darolutamide and leuprolide
Official title: A Phase 2 Trial of Darolutamide plus Leuprolide Acetate in Advanced Androgen Receptor Positive Salivary Gland Cancer
Funded at Sloan-Kettering Inst Can Research · NIH-11444035 · Data updated 2026-11-12
A phase 2 trial tests whether combining a next-generation antiandrogen with hormone therapy helps people with advanced AR-positive salivary gland cancer.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Sloan-Kettering Inst Can Research NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | September 1, 2026 |
| Project end | August 31, 2030 |
| Funding year | 2026 |
| Award (this year) | $2,583,632 |
| NIH project number | 1R01FD008542-01A1 |
| Project ID | NIH-11444035 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults with unresectable, locally advanced, or metastatic AR-positive salivary gland cancer (especially salivary duct carcinoma) who have not had adequate responses to standard therapies.
✕Less likely to help
Patients whose tumors do not express the androgen receptor or who cannot tolerate the treatment may not benefit.
What this research studies
If you have a salivary gland cancer that cannot be surgically removed or has spread, this trial looks at a treatment aimed at blocking the androgen receptor. Participants receive darolutamide along with leuprolide acetate to more effectively shut down the cancer’s growth signals. The study uses a US-based protocol to measure how well this combination works and how safe it is over time. Researchers will monitor tumor response, progression-free survival, and overall outcomes to determine if this approach offers meaningful benefit for patients. The trial is led by Sloan Kettering in New York and is designed for those whose disease expresses the androgen receptor.
Why it matters
Potential benefit: If successful, the treatment could slow or shrink tumors and improve control of the disease for patients with AR-positive salivary gland cancer.
How similar studies have gone: Previous AR-targeted trials in this cancer have shown variable responses; this US-based trial aims to improve on prior results with a more effective AR blockade.
Where this research is happening
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Sloan-Kettering Inst Can Research
New York, United States Active
Researchers
- Principal investigator: Ho, Alan L. — Sloan-Kettering Inst Can Research
- Study coordinator: Ho, Alan L.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.