Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Sacituzumab govitecan

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunoconjugates

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

Dose: 15 μg/kg subcutaneously (SC)

Frequency: administered on Day 8 of each cycle (every 3 weeks)

N-803

Dose: \~2 × 10\^9 cells intravenously (IV)

Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)

PD-L1 t-haNK

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)

Sacituzumab Govitecan-Hziy

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)

Bobby Reddy, MD

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.

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.

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

Determine the MTD or HTD and designate a recommended phase 2 dose (RP2D)

Incidence of dose limiting toxicities, treatment-emergent adverse events, and serious adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies	NCT04927884	Advanced Triple...	N-803 PD-L1 t-haNK Sacituzumab Gov... Cyclophosphamid...	18 Years -	ImmunityBio, Inc.
A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies	NCT04927884	Advanced Triple...	N-803 PD-L1 t-haNK Sacituzumab Gov... Cyclophosphamid...	18 Years -	ImmunityBio, Inc.

Spots Global Cancer Trial Database for stage iv tnbc