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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.

Trial ID or NCT#

NCT02576548

Status

NOT RECRUITING

Purpose

This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.

Official Title

A Phase 1/2 Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects With Select HER2-expressing Advanced Solid Tumors

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 18 years. 2. Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy. 1. For subjects with breast cancer: - Prior treatment with trastuzumab, pertuzumab, and T-DM1, either alone or in combination, is required. - Subjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible. - Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276. 2. For subjects with gastric cancer: - Prior treatment with a trastuzumab containing chemotherapy regimen is required. 3. HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue. 4. At least one lesion measurable by RECIST Version 1.1.

Exclusion Criteria:

1. Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276. 2. History of exposure to the following cumulative doses of anthracyclines: 1. Doxorubicin or liposomal doxorubicin >350 mg/m². 2. Epirubicin >530 mg/m². 3. Mitoxantrone >90 mg/m² and idarubicin > 70 mg/m². 4. If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin. 3. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery or other therapy to control symptoms from brain metastases within 2 months prior to first dose of MEDI4276.

View All Criteria

Investigator(s)

Mark Pegram

Medical oncologist, Breast specialist

Susy Yuan-Huey Hung Professor

Melinda L. Telli, M.D.

Medical oncologist, Breast specialist

Associate Professor of Medicine (Oncology)

George W. Sledge Jr., M.D.

Medical oncologist, Breast specialist

Professor of Medicine (Oncology)

CONTACT

Karen Lau
(650) 723-0658

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A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To:

New to MyHealth?

ALREADY HAVE AN ACCESS CODE?

DON'T HAVE AN ACCESS CODE?

NEED MORE DETAILS?

MyHealth for Mobile

WELCOME BACK

A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: