A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

  • STATUS
    Recruiting
  • End date
    Jul 4, 2022
  • participants needed
    352
  • sponsor
    MacroGenics
Updated on 7 July 2021
cancer
monoclonal antibodies
measurable disease
HER2
solid tumour
erbb2

Summary

The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD013 and establish the maximum tolerated dose (MTD) of MGD013. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of MGD013 will also be assessed.

Description

This is a Phase 1, open-label, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of MGD013 administered by IV infusion every 2 weeks. The study consists of a Dose Escalation Phase to determine the MTD or maximum administered dose (MAD) of MGD013 if no MTD is defined, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of MGD013 with the dose established in the Dose Escalation Phase.

In the Dose Escalation Phase, MGD013 will be evaluated in sequential escalating flat doses in successive cohorts of 1 to 6 patients each. Upon completion of the Dose Escalation Phase, a Cohort Expansion Phase will be initiated at the MTD/MAD.

Patients with unresectable, locally advanced or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. The Cohort Expansion Phase will be limited to selected cohorts of patients with unresectable, locally advanced or metastatic solid tumors or hematologic malignancies for whom there is no available therapy likely to confer clinical benefit. Two additional cohorts will enroll patients with gastric/gastroesophageal cancer or epithelial ovarian cancer, with MGD013 given every 3 weeks.

A separate cohort will evaluate the combination of MGD013 with margetuximab (anti-HER2 monoclonal antibody) in approximately 99 patients, in subgroups with HER2-positive gastric or gastroesophageal cancer, HER2-positive breast cancer, and any other HER2-positive cancer.

Details
Condition Non-Small Cell Lung Cancer, Cervical Cancer, Adenocarcinoma, Ovarian disorder, Hematologic Malignancy, Disorders of cervix NOS, Diffuse Large B-Cell Lymphoma, Cholangiocarcinoma, Blood disorder, Uterine Cancer, Ovarian Cancer, Squamous cell carcinoma, Small Cell Lung Cancer, Gastropathy, Gastric Cancer, head and neck cancer, Stomach Discomfort, Ovarian Function, Advanced Solid Tumors, HER2 Positive Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, Gastroesophageal Cancer, Squamous Cell Carcinoma of Head and Neck, Gastric Carcinoma, Recurrent Ovarian Cancer, HER2 Positive Gastric Cancer, Blood Cancer, Stomach Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, cervical carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, gastric cancers, her2/neu-positive breast cancer, her2-positive breast cancer, diffuse large cell lymphoma, diffuse large b cell lymphoma, nsclc, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, ovarian tumors, sclc, small cell carcinoma, small cell carcinoma of the lung, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies, TNBC - Triple-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Treatment MGD013, MGD013 in combination with margetuximab
Clinical Study IdentifierNCT03219268
SponsorMacroGenics
Last Modified on7 July 2021

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