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

NCT05008510 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: V2011801
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the following:

1. 1.The efficacy of sabizabulin monotherapy to sacituzumab govitecan-hziy monotherapy
2. 2.The efficacy of sacituzumab govitecan-hziy/sabizabulin combination therapy to sacituzumab govitecan-hziy monotherapy

Conditions

Metastatic Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• To compare the efficacy of sabizabulin monotherapy to Sacituzumab govitecan-hziy monotherapy

  The comparison 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.

  360 days

• To compare the efficacy of Sacituzumab govitecan-hziy/sabizabulin combination therapy to Sacituzumab govitecan-hziy monotherapy

  The comparison 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.

  360 days

Secondary Outcomes (1)

• Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (PR or CR) on study

  360 days

Study Arms (3)

Sabizabulin Monotherapy

EXPERIMENTAL

Subjects in the Sabizabulin Treated Group will receive sabizabulin 32 mg each day by mouth until disease progression confirmed by BICR is observed.

Drug: Sabizabulin

Sacituzumab govitecan-hziy/Sabizabulin Combination

EXPERIMENTAL

Subjects in the Sacituzumab govitecan-hziy /Sabizabulin Combination Treated Group will receive sabizabulin 32 mg each day by mouth and Sacituzumab govitecan-hziy at the FDA approved dose and dosage regimen for mTNBC until disease progression confirmed by BICR is observed.

Drug: Sabizabulin/Sacituzumab govitecan-hziy Combo

Sacituzumab govitecan-hziy Monotherpy

ACTIVE COMPARATOR

Subjects in the Control Treated Group will receive Sacituzumab govitecan-hziy intravenous infusion of 10 mg/kg in accordance with the FDA approved use and dosage regimen for mTNBC until disease progression confirmed by BICR is observed.

Drug: Sacituzumab Govitecan-hziy

Interventions

Sabizabulin DRUG

Sabizabulin (Veru-111)

Also known as: Veru-111

Sabizabulin Monotherapy

Sacituzumab Govitecan-hziy DRUG

Sacituzumab govitecan-hziy

Sacituzumab govitecan-hziy Monotherpy

Sabizabulin/Sacituzumab govitecan-hziy Combo DRUG

Sabizabulin/Sacituzumab govitecan-hziy Combo therpy

Also known as: Sacituzumab govitecan-hziy and Veru-111 combo

Sacituzumab govitecan-hziy/Sabizabulin Combination

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent
• Be able to communicate effectively with the study personnel
• Aged ≥18 years
• For Female Subjects
• Menopausal status Be postmenopausal as defined by the National Comprehensive Cancer
• Network as either:
• Age ≥55 years and one year or more of amenorrhea
• Age \<55 years and one year or more of amenorrhea, with an estradiol assay \<20 pg/mL
• Age \<55 years and surgical menopause with bilateral oophorectomy Be premenopausal or perimenopausal with a negative urine pregnancy test. If subject is of child-bearing potential, the subject must agree to use acceptable methods of contraception:
• If female study participant could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}
• If female study participant has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
• If female study participant has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
• For Male Subjects
• Subject must agree to use acceptable methods of contraception:
• If the study subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)

You may not qualify if:

• Women who are pregnant or lactating
• Women of childbearing potential or fertile men with a female partner of childbearing potential not willing to use effective contraction during the study and 6 months after last dose of study drug for the women of childbearing potential participating in the study and for 3 months after last dose of study drug in fertile men with a female partner of childbearing potential.
• Known hypersensitivity or allergy to sabizabulin or Sacituzumab govitecan-hziy
• Patients with biliary catheter
• Creatinine Clearance ≤60 mL/min by the Cockroft-Gault equation
• Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years (note: subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or cervical carcinoma in situ that have undergone potentially curative therapy are not excluded)
• Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
• Infection requiring antibiotic use within one week or randomization or uncontrolled infection.
• Treatment with any investigational product within \< 4 half-lives for each individual investigational product OR within 28 days prior to randomization
• Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment

Sponsors & Collaborators

• Veru Inc.: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sabizabulin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Barnette

  Veru Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Central reader for scans will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a multicenter, randomized, open-label, three treatment-arm, efficacy and safety study. Subjects will be randomized to the three treatment arms.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: December 30, 2021
• Primary Completion: July 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 8, 2022

Record last verified: 2022-01