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

NCT05008510 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sabizabulin

Sabizabulin (Veru-111)

DRUG

Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy

DRUG

Sabizabulin/Sacituzumab govitecan-hziy Combo

Sabizabulin/Sacituzumab govitecan-hziy Combo therpy

Sponsors & Collaborators

  • Veru Inc.

    lead INDUSTRY

Principal Investigators

  • Barnette · Veru Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2022-07-30
Completion
2023-06-30
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008510 on ClinicalTrials.gov