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
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
Drug | Synonyms | Arms |
---|
CX-2009 | | ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative |
CX-072 | | ARM 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
Name | Type | Description | Interventions |
---|
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 | |
ARM B - CX-2009 Monotherapy, TNBC | Experimental | CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC) | |
ARM C - CX-2009 Combination therapy, TNBC | Experimental | CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC | |
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: | 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
August 4, 2021