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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)

CONTACT

CCTO
(650) 498-7061

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View on ClinicalTrials.gov

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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: