A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.
Trial ID or NCT#
Status
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
- 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.
- 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)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov