CLINICAL TRIALS PROFILE FOR VERU-111
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Clinical Trials for VERU-111
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03752099 ↗ | To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer | Active, not recruiting | Veru Inc. | Phase 1/Phase 2 | Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC). Phase 2 - To estimate the PSA50 response rate, defined as a decline in PSA to ≥50% of baseline level, confirmed with a second measurement at least 3 weeks apart (PCWG3). |
| NCT04388826 ↗ | COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111 | Completed | Veru Inc. | Phase 2 | To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO). |
| NCT04842747 ↗ | VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study | Recruiting | Veru Inc. | Phase 3 | To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60). |
| NCT04844749 ↗ | Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent | Recruiting | Veru Inc. | Phase 3 | To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival. |
| NCT05008510 ↗ | P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC . | Not yet recruiting | Veru Inc. | Phase 2 | To compare the following: 1. The efficacy of sabizabulin monotherapy to sacituzumab govitecan-hziy monotherapy 2. The efficacy of sacituzumab govitecan-hziy/sabizabulin combination therapy to sacituzumab govitecan-hziy monotherapy These comparisons will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint. |
| NCT05079360 ↗ | Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer | Not yet recruiting | Veru Inc. | Phase 2 | To demonstrate the efficacy of sabizabulin in the treatment of estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for VERU-111
Condition Name
| Condition Name | |
| Intervention | Trials |
| Metastatic Breast Cancer | 1 |
| Metastatic Castration Resistant Prostate Cancer | 1 |
| Metastatic Castration-resistant Prostate Cancer | 1 |
| Metastatic Triple Negative Breast Cancer | 1 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for VERU-111
Trials by Country
Clinical Trial Progress for VERU-111
Clinical Trial Phase
Clinical Trial Sponsors for VERU-111
Sponsor Name
