To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.
Signed written and voluntary informed consent.
Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Age 18 years or older male or female.
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Inability to comply with study and follow-up procedures.
History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
Active infection requiring antibiotics.
Other invasive malignancy within 2 years except for malignancies determined to have low recurrence potential in discussion with study PI.
Single group
Seviteronel-D (Seivteronel in combination with dexamethasone)
DrugUse of Seviteronel-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours.
Docetaxel
DrugUse of docetaxel chemotherapy for solid tumours
Recommended phase 2 dose of seviteronel plus dexamethasone and docetaxel
A patient will be considered evaluable for dose limiting toxicity (DLT) if they have completed two cycles of docetaxel in an 8-week period with at least 80% of the planned INO-464 dose. Toxicity will be graded using CTCAE version 5.0
Number of patients with treatment-related adverse events
Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v5.0
Overall response rate (ORR)
The proportion of patients with a confirmed complete response or partial response as determined by the investigator according to RECIST v1.1
Duration of response (DoR)
The time from the first occurrence of a documented confirmed complete response or partial response to the first date of recorded disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first)
Overall survival (OS)
The time from starting the study treatment to death from any cause
Gene expression signatures in tumour biopsies treated with seviteronel
Gene expression analysis (RNAseq, or single-cell RNAseq) on tumor biopsies in response to study treatments.
Androgen receptor protein signature in biopsies treated with seviteronel
Expression of androgen receptor, ZEB1 and other protein markers in tumor biopsies in response to study treatment
Biomarker expression in blood and/or tumor tissue following seviteronel treatment
Gene expression and/or ctDNA analysis in blood and/or tumour biopsies in response to the study treatments.
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