A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

NOT ENROLLING
Protocol # :
21-130
Conditions
Neoplasms
Breast Neoplasms
Breast Neoplasms, Triple-Negative
Breast Cancer
Breast Neoplasms, Hormone Receptor Positive/HER2 Negative
Phase
II
Disease Sites
Breast
Principal Investigator
Lynce, Filipa
Site Research Nurses
Abraham, Elizabeth
Aspessi, Michael, William
Beeler, Maureen
Bowers, Jordan
Campbell, Margaret
Caradonna, Lisa
Casella, Allison
Dishman, Rachel, C.
Ficociello, Samantha
Jeon, Maryangel, H.
Kasparian, Elizabeth
Macauley, Colleen
Orechia, Meghan
Padden, Sarah
Patel, Nikita
Roche, Kathleen, A.
Rutter, Morgan
Shellock, Maria
Weitz, MaryAnn

Trial Description

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009
monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC,
and evaluate CX-2009+CX-072 in TNBC

Eligibility Requirements

INCLUSION CRITERIA:

- Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast
cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the
inoperable, locally advanced, or metastatic setting

- Arm B and Arm C: inoperable, locally advanced or metastatic TNBC; archival or fresh
tumor tissue must have high CD166 expression by immunohistochemistry (IHC). Patients
must have received 1 - 3 prior lines of therapy for inoperable, locally advanced, or
metastatic TNBC

- Arm C only: Patients must be Programmed Death Ligand 1 (PD-L1) positive by an
FDA-approved test. For patients who have received prior checkpoint inhibitors (CPI)
therapy: if the CPI was the most recent treatment given prior to enrollment into this
study, the patient must not have progressed within 120 days of the first dose of the
CPI

- Measurable disease per RECIST v1.1

- Adults, at least 18 years of age

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Adequate baseline Laboratory Values

- Patients of childbearing potential or those with partners of childbearing potential
must agree to use a highly effective method of birth control at least 1 month prior to
first dose, during study treatment, and for a period of 50 days after the last dose of
CX-2009 and 105 days after the last dose of CX-072 (Arm C).

- Patients with brain metastases that are ≤ 1 cm, are asymptomatic, and require no
treatment may be eligible after discussion with Medical Monitor.

- Additional inclusion criteria may apply

EXCLUSION CRITERIA:

- History of malignancy that was active within the previous 2 years. Exceptions include
localized cancers that are not related to the current cancer being treated, that are
considered to have been cured, and in the opinion of the Investigator present a low
risk for recurrence

- Untreated symptomatic brain and/or leptomeningeal metastases

- Unresolved prior therapy-related acute toxicity Grade > 1, including neuropathy.
Alopecia and other nonacute toxicities are not exclusionary

- Active or chronic corneal disorder

- Serious concurrent illness

- History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone
marrow transplant

- Arm C only:

- History of or current active autoimmune diseases

- History of myocarditis regardless of the cause

- History of intolerance to prior immune CPI therapy defined as the need to
discontinue treatment due to an immune-related Adverse Event (AE)

- Immunosuppressive therapy including chronic systemic steroid (≥ 10 mg daily
prednisone equivalents) within 14 days of Cycle 1 Day 1 (C1D1). However, patients
who require brief courses of steroids (eg, as prophylaxis for IV contrast or for
treatment of an allergic reaction) may be eligible with Medical Monitor approval.
Inhaled or topical steroids are permitted.

- History of severe allergic or anaphylactic reactions to previous monoclonal antibody
(mAb) therapy or known hypersensitivity to any component of Probody therapeutic

- Prior treatment with maytansinoid-containing drug conjugates (eg, DM1 or DM4 antibody
drug conjugate, including trastuzumab emtansine)

- Pregnant or breastfeeding

- Additional exclusion criteria may apply

21-130