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Advanced Triple Negative Breast CancerPhase 1/2NCT04927884

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

A Phase 1/2 study testing N-803, PD-L1 t-haNK and Sacituzumab Govitecan-Hziy in people with Advanced Triple Negative Breast Cancer, run by ImmunityBio, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Triple Negative Breast Cancer
What is being tested?
N-803, PD-L1 t-haNK and Sacituzumab Govitecan-Hziy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
8 Sep 2021to 12 Dec 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
  • Histologically confirmed stage IV TNBC. Subjects must have had at least 2 prior treatments for TNBC. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and progesterone receptor (PgR) expression (both ≤ 1% of tumor cell nuclei), and human epidermal growth factor receptor 2 (HER2) overexpression and/or amplification (IHC 0 or 1+, or IHC 2+ and fluorescence in situ hybridization [FISH]-), according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guideline criteria, as evaluated by local institutions.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
  • Have at least 1 measurable lesion of ≥ 1.0 cm and/or non-measurable disease evaluable in accordance with RECIST V1.1.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 5 months after the last dose of study treatment. Non-sterile male subjects must agree to use a condom while on study and for up to 5 months after the last dose of study treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.

Who cannot join

  • Have previously received or are currently receiving treatment with sacituzumab govitecan-hziy.
  • Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
  • Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
  • History of organ transplant requiring immunosuppression.
  • History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  • Inadequate organ function, evidenced by the following laboratory results:
Show all 21Show fewer
  • Absolute neutrophil count (ANC) < 1500 cells/mm3.
  • Platelet count < 75,000 cells/mm3.
  • Hemoglobin < 9 g/dL.
  • Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
  • Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
  • Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
  • Serum creatinine > 2.0 mg/dL or 177 μmol/L.
  • Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Known hypersensitivity to any component of the study medication(s).
  • Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  • Known uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) gene polymorphism resulting in reduced function.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women. A negative serum pregnancy test during screening and a negative pregnancy test within 72 hours prior to the first dose must be documented before study drug is administered to a female subject of child-bearing potential.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
N-803, PD-L1 t-haNK, Sacituzumab Govitecan-Hziy, Cyclophosphamide
Keywords
Chemoimmunotherapy, Stage IV TNBC, Sacituzumab, N-803, PD-L1 t-haNK, Cyclophosphamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-803Biological

    Dose: 15 μg/kg subcutaneously (SC)

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

  • PD-L1 t-haNKBiological

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

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

  • Sacituzumab Govitecan-HziyDrug

    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)

  • CyclophosphamideDrug

    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)

Study groups in NCT04927884
Study groupRoleWhat they receive
All subjectsExperimentalSacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK)
Receives: Biological: N-803; Biological: PD-L1 t-haNK; Drug: Sacituzumab Govitecan-Hziy; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events

    Measured: 30 days after last dose, up to 65 weeks and 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start8 Sep 2021
  3. Primary completion13 Sep 2022
  4. Study completion12 Dec 2022

Why it stopped: low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04927884
Sponsor's protocol ID
QUILT-3.058
Status last verified
Jun 2024
First submitted
9 Jun 2021
Last updated
12 Jun 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing N-803, PD-L1 t-haNK and Sacituzumab Govitecan-Hziy in people with Advanced Triple Negative Breast Cancer, run by ImmunityBio, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (time frame: 30 days after last dose, up to 65 weeks and 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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