A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.
NCT ID: NCT02576548
Last Updated: 2019-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2015-09-23
2018-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MEDI4276 0.05 mg/kg
Participants received IV dose of 0.05 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.1 mg/kg
Participants received IV dose of 0.1 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.2 mg/kg
Participants received IV dose of 0.2 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.3 mg/kg
Participants received IV dose of 0.3 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.4 mg/kg
Participants received IV dose of 0.4 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.5 mg/kg
Participants received IV dose of 0.5 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.6 mg/kg
Participants received IV dose of 0.6 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.75 mg/kg
Participants received IV dose of 0.75 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
MEDI4276 0.9 mg/kg
Participants received IV dose of 0.9 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
MEDI4276
MEDI4276 is an investigational product
Interventions
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MEDI4276
MEDI4276 is an investigational product
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune LLC
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Research Site
Stanford, California, United States
Research Site
Sarasota, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Nashville, Tennessee, United States
Countries
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References
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Faria M, Peay M, Lam B, Ma E, Yuan M, Waldron M, Mylott WR Jr, Liang M, Rosenbaum AI. Multiplex LC-MS/MS Assays for Clinical Bioanalysis of MEDI4276, an Antibody-Drug Conjugate of Tubulysin Analogue Attached via Cleavable Linker to a Biparatopic Humanized Antibody against HER-2. Antibodies (Basel). 2019 Jan 11;8(1):11. doi: 10.3390/antib8010011.
Other Identifiers
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D5760C00001
Identifier Type: -
Identifier Source: org_study_id
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