NCT05008510 (VERU-111) is a Phase 2 clinical trial of Sabizabulin in Metastatic Triple Negative Breast Cancer, sponsored by Veru Inc..

Who is sponsoring NCT05008510?

NCT05008510 is sponsored by Veru Inc..

What drugs are being tested in NCT05008510?

Interventions in NCT05008510: Sabizabulin, Sacituzumab Govitecan-hziy, Sabizabulin/Sacituzumab govitecan-hziy Combo.

What condition does NCT05008510 study?

NCT05008510 studies Metastatic Triple Negative Breast Cancer.

Is NCT05008510 still recruiting?

NCT05008510 is currently withdrawn. Last updated 8 February 2022.

Last reviewed 2022-02-08 · How we verify

NCT05008510: VERU-111

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .

Withdrawn Phase 2 Last updated 8 February 2022

What this trial tests

Phase 2 trial testing Sabizabulin in Metastatic Triple Negative Breast Cancer. Withdrawn.

Timeline

30 December 2021

Primary endpoint
30 July 2022

30 June 2023

Quick facts

Lead sponsor	Veru Inc.
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	30 December 2021
Primary completion	30 July 2022
Estimated completion	30 June 2023

Drugs / interventions tested

Sabizabulin — full drug profile →
Sacituzumab Govitecan-hziy — full drug profile →
Sabizabulin/Sacituzumab govitecan-hziy Combo — full drug profile →

Conditions studied

Metastatic Triple Negative Breast Cancer — all drugs for Metastatic Triple Negative Breast Cancer →

Sponsor

Veru Inc. — full company profile →

Who can join

Adults 18 to 100, any sex, with Metastatic Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Advances in Trop-2 targeted antibody-drug conjugates for breast cancer: mechanisms, clinical applications, and future directions.
Tong Y, Fan X, Liu H, Liang T. · · 2024 · cited 20× · PMID 39555080 · DOI 10.3389/fimmu.2024.1495675
Exploring the therapeutic potential of ADC combination for triple-negative breast cancer.
Lu L, Niu Z, Chao Z, Fu C, et al · · 2023 · cited 14× · PMID 37930428 · DOI 10.1007/s00018-023-04946-x
TROP2-targeting antibody-drug conjugates in breast cancer and ovarian carcinoma: therapeutic advances and resistance mechanisms.
Eroles P, Dawid de Vera MT, Lago V. · · 2026 · PMID 42040770 · DOI 10.20517/cdr.2025.195

Verify or expand the search:

Other trials of Sabizabulin

Trials testing the same drug.

NCT05079360 — Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer · Phase 2 · withdrawn

Other recruiting trials for Metastatic Triple Negative Breast Cancer

Currently open trials in the same condition.

NCT03330847 — To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. · Phase 2 · active not recruiting

Other Veru Inc. trials

Trials by the same sponsor.

NCT06282458 — Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt · Phase 2 · completed
NCT05079360 — Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer · Phase 2 · withdrawn
NCT05065411 — Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer · Phase 3 · terminated
NCT04869943 — Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer · Phase 3 · terminated
NCT04844749 — Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05008510 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Veru Inc.
Last refreshed: 8 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05008510.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing