Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

Phase II Study of Darolutamide (ODM-201) in Patients With Androgen Receptor-positive Salivary Gland Carcinoma (Discovary Study)

This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen receptor-positive salivary gland carcinoma.

Inclusion Criteria:

Darolutamide monotherapy group:

1. Signed, written informed consent.
2. Patients older than 20 years.
3. Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma (AC)(NOS), or Carcinoma ex pleomorphic adenoma.
4. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
5. Presence of measurable or evaluable disease according to RECIST v1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7. Adequate organ or bone marrow function
8. Patients who agree to practice effective barrier contraception and refrain from sperm donation during the entire study treatment period and 3 months after the last dose of the study drug.

Darolutamide and Goserelin combination therapy group:

1. Signed, written informed consent.
2. Patients older than 20 years.
3. Histologically confirmed as androgen receptor-positive salivary gland carcinoma at the medical institution.
4. Histologically confirmed as salivary gland carcinoma at the medical institution.
5. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
6. Presence of measurable or evaluable disease according to RECIST v1.1
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
8. Adequate organ or bone marrow function
9. Patients who agree to practice effective barrier contraception refrain from sperm donation and stop breastfeeding during the entire study treatment period and through 3 months after the last dose of the study drug.

Exclusion Criteria:

Darolutamide monotherapy group:

1. Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.

2. Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.

3. Metastases in the brain/central nervous system (CNS).

4. Patients who are pregnant or breastfeeding.

5. Synchronous or metachronous malignancies.

6. Participant has a known history of HIV infection.

7. A positive test result for any of the followings:

   • HBsAg positive
   • HBsAb positive and hepatitis B virus (HBV)-DNA positive
   • HBcAb positive and HBV-DNA positive

8. Severe or uncontrolled concurrent heart disease or hypertension.

9. Inability to swallow oral medications.

Darolutamide and Goserelin combination therapy group:

1. Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex Hormones, or Gonadotropin

2. Prior treatment with Darolutamide or Goserelin.

3. Metastases in the brain/CNS.

4. Patients who are pregnant or breastfeeding.

5. Synchronous or metachronous malignancies.

6. Participant has a known history of HIV infection.

7. A positive test result for any of the followings:

   • HBsAg positive
   • HBsAb positive and HBV-DNA positive
   • HBcAb positive and HBV-DNA positive

8. Severe or uncontrolled concurrent heart disease or hypertension.

9. Inability to administer Darolutamide or Goserelin.