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CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative
Breast Cancer

Trial Status: Active

Description

This phase I trial tests the safety, side effects, and best dose of
CF33-hNIS-antiPDL1 in treating patients with triple negative breast
cancer that has spread to other places in the body (metastatic).
CF33-hNIS-antiPDL1 is an oncolytic virus. This is a virus that is
designed to infect tumor cells and break them down.

Eligibility Criteria

Inclusion Criteria

  * Documented informed consent of the participant and/or legally
    authorized representative * Assent, when appropriate, will be
    obtained per institutional guidelines
  * Agreement to research biopsies on study, once during study and
    end of study, exceptions may be granted with study principal
    investigator (PI) approval
  * >= 18 years
  * Eastern Cooperative Oncology Group (ECOG) =< 2
  * Histologically confirmed metastatic triple negative breast
    cancer. Triple negative status will be defined as estrogen
    receptor (ER) and progesterone receptor (PR) =< 10% by
    immunohistochemistry (IHC) and HER2 negative, per American
    Society of Clinical Oncology/College of American Pathologists
    (ASCO/CAP) guidelines
  * Measurable disease by RECIST 1.1
  * Patients must have progressed on or been intolerant of at least 2
    prior lines of therapy for advanced/metastatic disease. Patients
    that qualify for immunotherapy and/or PARP inhibitors must have
    progressed on or been intolerant of these agents
  * Fully recovered from the acute toxic effects (except alopecia) to
    =< grade 2 to prior anti-cancer therapy
  * Must have a superficial tumor (cutaneous, subcutaneous), breast
    lesion or nodal metastases amenable to safe repeated intratumoral
    injections per treating physician and interventional radiologist
    review
  * Absolute neutrophil count (ANC) >= 1,500/mm^3 * NOTE: Growth
    factor is not permitted within 14 days of ANC assessment unless
    cytopenia is secondary to disease involvement
  * Platelets >= 100,000/mm^3 * NOTE: Platelet transfusions are not
    permitted within 14 days of platelet assessment unless cytopenia
    is secondary to disease involvement
  * Total bilirubin =< 1.5 X upper limit of normal (ULN)
  * Aspartate aminotransferase (AST) =< 2.5 x ULN * If liver
    metastases are present: AST =< 5 x ULN
  * Alanine aminotransferase (ALT) =< 2.5 x ULN * If liver metastases
    are present: ALT =< 5 x ULN
  * Serum creatinine =< 1.5 mg/dL or creatinine clearance of >= 50 mL
    /min per 24 hour urine test or the Cockcroft-Gault formula
  * Prothrombin (PT) =< 1.5 x ULN
  * Activated partial thromboplastin time (aPTT) =< 1.5 x ULN
  * Women of childbearing potential (WOCBP): negative serum pregnancy
    test
  * Agreement by females and males of childbearing potential* and
    their partners to use an effective method of birth control
    (defined as a hormonal or barrier method) or abstain from
    heterosexual activity for the course of the study through at
    least 6 months after the last dose of protocol therapy *
    Childbearing potential defined as not being surgically sterilized
    (men and women) or have not been free from menses for > 1 year
    (women only)

Exclusion Criteria

  * Chemotherapy, biological therapy, immunotherapy or
    investigational therapy within 14 days prior to day 1 of protocol
    therapy
  * Major surgery or radiation therapy within 28 days of study
    therapy
  * Has received a vaccination within 30 days of first study
    injection
  * History of allergic reactions attributed to compounds of similar
    chemical or biologic composition to study agent
  * Clinically significant uncontrolled illness
  * Active infection requiring antibiotics
  * Known history of immunodeficiency virus (HIV)
  * Patients with a known history of hepatitis B or hepatitis C
    infection who have active disease as evidenced by hepatitis (Hep)
    B surface antigen status or Hep C polymerase chain reaction (PCR)
    status obtained within 14 days of cycle 1, day 1
  * Another malignancy within 3 years, except non-melanomatous skin
    cancer
  * Females only: Pregnant or breastfeeding
  * Patients may not have clinically unstable brain metastases.
    Patients may be enrolled with a history of treated brain
    metastases that are clinically stable for >= 4 weeks prior to
    start of study treatment
  * Any other condition that would, in the Investigator's judgment,
    contraindicate the patient's participation in the clinical study
    due to safety concerns with clinical study procedures
  * Prospective participants who, in the opinion of the investigator,
    may not be able to comply with all study procedures (including
    compliance issues related to feasibility/logistics)

Locations & Contacts

California

Duarte

City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Yuan Yuan
Phone: 626-218-4490
Email: yuyuan@coh.org

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To determine the safety and tolerability of a novel chimeric
oncolytic orthopoxvirus, oncolytic virus CF33-expressing hNIS/
Anti-PD-L1 antibody (CF33-hNIS-antiPDL1), by the evaluation of
toxicities including: type, frequency, severity, attribution, time
course, reversibility and duration according to Common Terminology
Criteria for Adverse Events (CTCAE) 5.0 criteria.

SECONDARY OBJECTIVES:

I. To determine the optimal biologic dose (OBD) (defined as a safe
dose that induces an immune response in tumors [increase checkpoint
target PD-L1 by at least 5% and/or increase T cell infiltration by at
least 10%]) and the recommended phase II dose (RP2D) for future
expansion trial.

II. To determine tumor response rates by Response Evaluation Criteria
in Solid Tumors (RECIST) version (v)1.1 (primary) and immune-modified
(i)RECIST (secondary).

III. To document possible therapeutic efficacy and evaluate
progression-free survival, overall survival and response.

EXPLORATORY OBJECTIVE:

I. To determine the immune and genomic profiles of tumors before and
after CF33-hNIS-antiPDL1 therapy.

OUTLINE: This is a dose-escalation study.

Patients receive CF33-hNIS-antiPDL1 intratumorally (IT) on days 1 and
15. Treatment repeats every 28 days for up to 3 cycles in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30
days, then every 3 months for 1 year.

Trial Phase & Type

Trial Phase Phase I

Trial Type Treatment

Lead Organization

Lead Organization
City of Hope Comprehensive Cancer Center

Principal Investigator
Yuan Yuan

Trial IDs

  * Primary ID 21094
  * Secondary IDs NCI-2021-08983
  * Clinicaltrials.gov ID NCT05081492

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