MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merus B.V.
Study ID
NCT03321981
Phase
PHASE2
Status
Completed

Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zenocutuzumab — DRUG
    full length immunoglobulin gamma-1 (IgG1) bispecific antibody targeting Human Epidermal Growth Factor Receptor (HER)2 and HER3
  • Trastuzumab — DRUG
    humanised IgG1 monoclonal antibody
  • Vinorelbine — DRUG
    antineoplastic drug of vinca alkaloid family
  • Endocrine therapy — DRUG
    same endocrine therapy is administered as the last line of endocrine therapy

Study Details

A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

Key Dates

Start date
Jan 15, 2018
Status verified
Feb 2024
Primary completion
Oct 26, 2022
Completion
Jul 26, 2023

Study Design

Enrollment
105 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 doublet
    zenocutuzumab + trastuzumab
  • Experimental: Cohort 1 triplet
    zenocutuzumab + trastuzumab + vinorelbine
  • Experimental: Cohort 2
    zenocutuzumab + endocrine therapy

Primary Outcome Measure

Clinical Benefit Rate at 24 Weeks [ Time Frame: 24 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
HCA Midwest HealthKansas CityKansas64131-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAHCA Midwest Health· Kansas City, KSSarah Cannon Research Institute· Nashville, TN

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