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Chemotherapy

Sacituzumab Govitecan-Hziy for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by ImmunityBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug in combination with other drugs to see if it is safe and effective in people with Triple Negative Breast Cancer who have had two or more other treatments.

Eligible Conditions

Triple Negative Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b: Maximum Tolerated Dose (MTD) or Highest Tolerated Dose (HTD)

Phase 1b: Safety Profile of sacituzumab plus chemoimmunotherapy

Phase 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1

Secondary outcome measures

Phase 1b: Disease Control Rate (DCR) per RECIST V1.1

Phase 1b: Duration of Response (DOR) per RECIST V1.1

Phase 1b: Overall Survival (OS)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: All subjectsExperimental Treatment4 Interventions

Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

N-803

2021

Completed Phase 2

~30

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Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor

63 Previous Clinical Trials

5,133 Total Patients Enrolled

Bobby Reddy, MDStudy DirectorImmunityBio, Inc.

4 Previous Clinical Trials

629 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For which medical conditions is Sacituzumab Govitecan-Hziy commonly prescribed?

"Sacituzumab Govitecan-Hziy has been effective in treating a variety of maladies including multiple sclerosis, leukemia, myelocytic disorders, acute conditions and retinoblastoma."

Answered by AI

What is the upper limit for enrollees of this medical experiment?

"This trial is no longer recruiting participants, which it started doing on September 27th 2021. For individuals seeking other clinical trials, 2346 breast cancer studies are actively enrolling and 863 Sacituzumab Govitecan-Hziy related medical research projects require volunteers."

Answered by AI

Are there any vacancies for participants in this experiment?

"Clinicaltrials.gov states that this clinical trial is not presently accepting participants, although it was listed on September 27th 2021 and last updated March 29th 2022. Nevertheless, there are over three thousand other medical studies actively recruiting patients as of now."

Answered by AI

Could you please elucidate any other investigations conducted on Sacituzumab Govitecan-Hziy?

"Presently, 863 trials are in progress which involve Sacituzumab Govitecan-Hziy. Of those studies 162 fall into the Phase 3 category. While Philadelphia is a hub for research regarding this medication, there are 29720 locations running trails for it worldwide."

Answered by AI

What is the ultimate goal of this experiment?

"ImmunityBio, Inc., the clinical trial sponsor, has established that the primary outcome they will evaluate across a one year period is Sacituzumab-chemoimmunotherapy's safety profile. Furthermore, this study also intends to measure secondary outcomes such as Phase 1b: ORR per RECIST V1.1 (Phase 1b Secondary Endpoint), PFS per RECIST V1.1 (Phase 1b Secondary Endpoint) and OS (Phase 2 Secondary Endpoint)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies

2021. "A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04927884.