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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Margenza (margetuximab-cmkb) (HER2 inhibitor) + tebotelimab (MGD013) (PD1 inhibitor, LAG-3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
Excerpt:
...HER2+ Cohort...Locally advanced or metastatic HER2+ locally advanced or metastatic solid tumors, regardless of organ of origin...The cancer must have progressed following standard therapy, or has progressed during or after HER2-directed therapy if approved and available for patients with HER2+ breast, gastric, or gastroesophageal junction cancer...History of HER2 positivity defined as 3+ by IHC or 2+ by IHC in combination with in situ hybridization (ISH) positivity most recent tumor biopsy...All patients in the HER2+ cohort must be willing to provide consent for a baseline and on-treatment tumor biopsy during the screening period and within 14 days prior to Cycle 3 Day 1. Exceptions may be made based on a medical contraindication at the discretion of the Sponsor's Medical Monitor. This requirement will be discontinued after an adequate number of samples are collected, as determined by the Sponsor...
Trial ID:
Source:
Title:
A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms.
Published date:
05/13/2020
Excerpt:
In a cohort of pts with HER2+ tumors treated with MGD013 in combination with margetuximab (investigational anti-HER-2 antibody), 3 PRs have been observed (breast [n=2], colorectal [n=1]; 1 cPR, 2 uPRs) and 2 pts with SD among 6 RE pts.
DOI:
10.1200/JCO.2020.38.15_suppl.3004
Trial ID:
