Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

NCT04596150 | Completed Phase 2 FDA Drug

• 2 other identifiers: CTMX-2009-0022020-004618-36
• Study Type: interventional
• Target: 125
• Locations: 3 countries
• Sites: 42

Brief Summary

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

Conditions

Neoplasms; Breast Neoplasms; Breast Neoplasms, Triple-Negative; Breast Cancer; Breast Neoplasms, Hormone Receptor Positive/HER2 Negative

Keywords

HR-positive/HER2-non-amplified; HR+; HER2 non-amplified; Hormone Receptor; N2'-deacetyl-N2'-(4-mercapto-4-methyl-1-oxopentyl)-maytansine (DM4); Cluster of Differentiation 166 (CD166); Triple negative breast cancer; Breast cancer; Probody; Armed antibody; Mytansine; Hormone Receptor Positive; DM4; CD166; PD-L1; Praluzatamab Ravtansine; Pacmilimab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Central Radiology Review (CRR)

  30 months

Secondary Outcomes (5)

• Investigator-assessed Progression-Free Survival (PFS)

  30 Months

• Duration of Response (DoR)

  30 Months

• Overall Survival (OS)

  30 Months

• Clinical Benefit Rate (CBR) at 16 Weeks

  30 Months

• Clinical Benefit Rate (CBR) at 24 Weeks

  30 Months

Study Arms (3)

ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative

EXPERIMENTAL

CX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer

Drug: CX-2009

ARM B - CX-2009 Monotherapy, TNBC

EXPERIMENTAL

CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)

Drug: CX-2009

ARM C - CX-2009 Combination therapy, TNBC

EXPERIMENTAL

CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC

Drug: CX-2009; Drug: CX-072

Interventions

CX-2009 DRUG

Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)

ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative; ARM B - CX-2009 Monotherapy, TNBC; ARM C - CX-2009 Combination therapy, TNBC

CX-072 DRUG

Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W)

ARM C - CX-2009 Combination therapy, TNBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CytomX Therapeutics: lead

Study Sites (42)

Moores Cancer Center

La Jolla, California, 92093, United States

Location

Los Angeles Hematology Oncology Medical

Los Angeles, California, 90017, United States

Location

USC Norris Cancer Center

Los Angeles, California, 90033, United States

Location

UCLA David Geffen

Santa Monica, California, 90404, United States

Location

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124, United States

Location

FCS - South

Fort Myers, Florida, 33901, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Hematology Oncology Assoc of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

FCS - North

St. Petersburg, Florida, 33705, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Hematology Oncology Clinic

Baton Rouge, Louisiana, 78809, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MGH

Boston, Massachusetts, 02114, United States

Location

DRCI

Boston, Massachusetts, 02215, United States

Location

Allina Health System

Minneapolis, Minnesota, 55407, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

UT Health East Texas HOPE Cancer Center

Tyler, Texas, 75701, United States

Location

Huntsman Cancer Institute Research

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Summit Cancer Centers

Spokane, Washington, 99208, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Soon Chun Hyang University Cheonan Hospital SCHMC

Cheonan, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Vall d'Hebron University Hospital

Barcelona, 08036, Spain

Location

Institut Catala Oncologia

Barcelona, 08908, Spain

Location

Hospital Universitario Ramn y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

NEXT Oncology

Madrid, 28050, Spain

Location

Hospital Parc Tauli

Sabadell, 08208, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Monika Vainorius, M.D.

  CytomX Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 22, 2020
• Study Start: December 29, 2020
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

KR (7); ES (8); US (27)