Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EPI-7386 · 1 trial · 3 indications
Defined as prostate-specific antigen (PSA) undetectable (\<0.2 ng/mL) at 6 months after treatment. The true BRR for the study population will be estimated based on the number of biochemical responses using a binomial distribution, and its confidence interval (CI) will be estimated using Wilson's method.
Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed
Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed
Objective response rate (ORR)
| Arm | Type | Description |
|---|---|---|
| EPI-7386 + Enzalutamide | EXPERIMENTAL | EPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles). |
| Name | Type | Description |
|---|---|---|
| EPI-7386 | DRUG | 600 mg orally administered twice daily |
| Enzalutamide | DRUG | 160 mg administered orally once daily, with or without food |
| Androgen Deprivation Therapy (ADT) | DRUG | LHRH agonist/antagonist or orchiectomy |
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed prostate adenocarcinoma without small cell or neuroendocrine features (please note: \>10% small cell or neuroendocrine differentiation will be excluded). * Subjects must have received no prior second-generation antia...
EPI-7386 is an investigational small molecule being studied for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). It is intended for use in combination with enzalutamide and androgen deprivation therapy. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
EPI-7386 is a small molecule that targets the androgen receptor pathway. It is being evaluated in combination with enzalutamide and androgen deprivation therapy for metastatic hormone-sensitive prostate cancer. The drug is designed to interfere with androgen receptor signaling, which plays a key role in prostate cancer growth.
EPI-7386 is being developed by ESSA Pharma Inc., a biopharmaceutical company. ESSA Pharma is publicly traded on the NASDAQ under the ticker symbol EPIX. The company is conducting clinical trials to evaluate the safety and efficacy of EPI-7386 in patients with metastatic hormone-sensitive prostate cancer.
EPI-7386 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of metastatic hormone-sensitive prostate cancer, and its safety and efficacy have not yet been established.
EPI-7386 has been studied in a Phase 2 clinical trial with the identifier NCT06312670. This trial evaluated the combination of EPI-7386 with enzalutamide and androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer. The study was completed and enrolled 13 participants in the United States.