NCT04927884

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

Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In part 1 of phase 1b, 3 to 6 subjects will be sequentially enrolled starting at dose level 1 and will be assessed for dose limiting toxicities (DLTs). Dose level cohorts for sacituzumab govitecan-hziy are as follows: * 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) In part 2 of phase 1b, dose expansion will occur when the RP2D has been determined. An additional 4 subjects may be enrolled, for a total of up to 10 subjects at the RP2D. Following part 2 of the phase 1b portion of the study, the Safety Review Committee (SRC) will meet to determine if enrollment into phase 2 should proceed. In the phase 2 portion of the study, 22 subjects will be enrolled at the RP2D in the first stage of Simon's two stage optimal design. If ≥ 9 of 22 subjects exhibit a confirmed response, the study will proceed to the second stage. If the study proceeds to the second stage, an additional 41 subjects will be enrolled for a total of 63 subjects in the phase 2. If ≥ 27 of the 63 subjects exhibit a confirmed response, the combination therapy will be considered for further development. All subjects may receive up to 17 cycles (ie, 51 weeks) of treatment administered in 3-week cycles.

Conditions

• Advanced Triple Negative Breast Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-09-08
• Primary completion: 2022-09-13
• Completion: 2022-12-12
• First posted: 2021-06-16
• Last updated: 2024-06-12
• Results posted: 2024-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study