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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
