NCT04927884 - A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 8, 2021

Primary Completion Date

September 13, 2022

Study Completion Date

December 12, 2022

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)"

Trial Locations (1)

92663

Hoag Memorial Hospital, Newport Beach