Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ES414 · 1 trial · 1 indication
Identify the maximum tolerated dose in dose-escalation stage (Stage 1) by assessment of dose-limiting toxicities
| Arm | Type | Description |
|---|---|---|
| ES414 | EXPERIMENTAL | Cohorts 1-3 of the dose escalation stage of the study (Stage 1) will test weekly doses of 0.2 mcg/kg to 2 mcg/kg. Cohorts 4-9 of the dose escalation stage of the study (Stage 1) will test continuous infusion at flat doses of 25 mcg to 300 mcg per day delivered continuously over 24 hours. The maximum tolerated dose from Stage 1 of the study will be further examined in Stage 2. Patients in cohorts 1-3 will receive ES414 weekly via intravenous (IV) infusion during the first three 28-day cycles and then on Day 1 and 15 of each subsequent cycle until disease progression, intolerable toxicity occurs, or the patient withdraws consent. Patients in cohorts 4-9 will receive ES414 as a continuous IV infusion for 6 months until disease progression, intolerable toxicity occurs, or the patient withdraws consent. |
| Name | Type | Description |
|---|---|---|
| ES414 | BIOLOGICAL | ES414 is a novel humanized bispecific antibody which is designed to treat mCRPC by redirecting T-cell cytotoxicity against prostate cancer cells expressing prostate-specific membrane antigen (PSMA). |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate. No evidence of neuroendocrine differentiation or small cell features. * Surgically or medically castrated, with testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L). * Progressive prostate cancer by either serum PSA l...
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ES414 is an investigational monoclonal antibody being developed for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ES414 is a monoclonal antibody designed to target prostate cancer cells. It is being studied for its ability to treat metastatic castration-resistant prostate cancer, a form of prostate cancer that has spread and no longer responds to hormone therapy.
ES414 is being developed by Aptevo Therapeutics Inc., a biopharmaceutical company. Aptevo is conducting clinical research on ES414 for the treatment of prostate cancer and is listed on the stock exchange under the ticker symbol APVO.
ES414 is in Phase 1 clinical development. A Phase 1 study of ES414 in patients with metastatic castration-resistant prostate cancer has been completed. The drug remains investigational and is not yet approved for commercial use.
ES414 has been studied in a Phase 1 clinical trial with the identifier NCT02262910, titled "Study of ES414 in Metastatic Castration-Resistant Prostate Cancer." This trial enrolled 35 male participants and was conducted in the United States and Australia. The trial has been completed.
ES414 is an investigational monoclonal antibody developed by Aptevo Therapeutics. It is being studied specifically for metastatic castration-resistant prostate cancer. No alternative names for ES414 have been reported in clinical trial registries.