Clinical Trials /

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

NCT04596150

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
  • Official Title: A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of CX-2009 in Advanced HR-Positive/HER2-Negative Breast Cancer and of CX-2009 as Monotherapy and in Combination With CX-072 in Advanced Triple-Negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: CTMX-2009-002
  • SECONDARY ID: 2020-004618-36
  • NCT ID: NCT04596150

Conditions

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

Interventions

DrugSynonymsArms
CX-2009ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative
CX-072ARM C - CX-2009 Combination therapy, TNBC

Purpose

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

Detailed Description

      Eligible patients will be enrolled to the treatment arm based on breast cancer subtype.

      Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009
      monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until
      disease progression or symptomatic deterioration, unacceptable toxicity necessitating
      treatment discontinuation, or if the patient meets certain study defined criteria for
      discontinuation. On-treatment tumor assessments, will occur every 6 weeks per RECIST v1.1 for
      the first 48 weeks, and every 12 weeks thereafter.
    

Trial Arms

NameTypeDescriptionInterventions
ARM A - CX-2009 Monotherapy, HR-positive/HER2-negativeExperimentalCX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer
  • CX-2009
ARM B - CX-2009 Monotherapy, TNBCExperimentalCX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)
  • CX-2009
ARM C - CX-2009 Combination therapy, TNBCExperimentalCX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
  • CX-2009
  • CX-072

Eligibility Criteria

        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
             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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:30 months
Safety Issue:
Description: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)

Secondary Outcome Measures

Measure:Investigator-assessed Progression-Free Survival (PFS)
Time Frame:30 Months
Safety Issue:
Description:The time from the date of the first dose of study treatment until documentation of objective tumor progression based on RECIST v1.1 or until death due to any cause
Measure:Duration of Response (DoR)
Time Frame:30 Months
Safety Issue:
Description:The time that measurement criteria are met for CR or PR (based on RECIST v1.1) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started)
Measure:Overall Survival (OS)
Time Frame:30 Months
Safety Issue:
Description:The time from treatment initiation until death as a result of any cause
Measure:Clinical Benefit Rate (CBR) at 16 Weeks
Time Frame:30 Months
Safety Issue:
Description:This will include sum of confirmed Complete plus Partial Responses plus stable disease at 16 weeks on treatment
Measure:Clinical Benefit Rate (CBR) at 24 Weeks
Time Frame:30 Months
Safety Issue:
Description:This will include sum of confirmed Complete plus Partial Responses plus stable disease at 24 weeks on treatment

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:CytomX Therapeutics

Trial 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

Last Updated

December 4, 2020