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

NCT04927884 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-06-12

Study results available
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Summary

This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects with Triple Negative Breast Cancer (TNBC) after at least 2 prior treatments for metastatic disease.

Conditions

  • Advanced Triple Negative Breast Cancer

Interventions

BIOLOGICAL

N-803

Dose: 15 μg/kg subcutaneously (SC) Frequency: administered on Day 8 of each cycle (every 3 weeks)

BIOLOGICAL

PD-L1 t-haNK

Dose: \~2 × 10\^9 cells intravenously (IV) Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)

DRUG

Sacituzumab Govitecan-Hziy

Phase 1b: Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV) Phase 2: Dose based on Phase 1b Recommended Phase 2 Dose (IV) Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)

DRUG

Cyclophosphamide

Dose: 25 mg capsules taken twice per day by mouth (PO) Frequency: to be taken Days 1-15 and 15-19 of each cycle (every 3 weeks)

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Bobby Reddy, MD · ImmunityBio, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2022-09-13
Completion
2022-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04927884 on ClinicalTrials.gov