A Phase 1 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors | Recruiting
A Phase 1 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors
Health Conditions
  • Solid Cancers
Recruiting
Recruitment Status
NCT01375842
Primary Trial ID Number
Summary
This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of MPDL3280A administered as single agent by intravenous (IV) infusion to patients with locally advanced or metastatic solid malignancies or hematologic malignancies.
Primary Outcome Measures
  • Incidence of dose limiting toxicities (DLTs); Up to day 21; Nature of dose limiting toxicities (DLTs); Up to day 21
Secondary Outcome Measures
  • Incidence of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first; Nature of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first; Severity of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first
Research Question
  • This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of MPDL3280A administered as single agent by intravenous (IV) infusion to patients with locally advanced or metastatic solid malignancies or hematologic malignancies.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United States; France; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
344
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Histologically or cytologically documented, incurable or metastatic solid tumor or
  • hematologic malignancy
  • - Representative tumor specimens in paraffin blocks/unstained slides, with an
  • associated pathology report
  • - Adequate hematologic and end organ function
  • - Measurable disease per RECIST for patients with solid malignancies or per
  • disease-specific criteria for patients with hematologic malignancies
  • - ECOG: 0-1
  • Exclusion Criteria:
  • - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • - History or risk of autoimmune disease (i.e. SLE, RA, inflammatory bowel disease, Type
  • I DM, autoimmune thyroid disease, vasculitis, etc.)
  • - History of HIV, hepatitis B, or hepatitis C infection
  • - Any signs or symptoms of infection
  • - Malignancies other than disease under study within 5 years
  • - Prior allogeneic stem cell transplant
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Histologically or cytologically documented, incurable or metastatic solid tumor or
  • hematologic malignancy
  • - Representative tumor specimens in paraffin blocks/unstained slides, with an
  • associated pathology report
  • - Adequate hematologic and end organ function
  • - Measurable disease per RECIST for patients with solid malignancies or per
  • disease-specific criteria for patients with hematologic malignancies
  • - ECOG: 0-1
  • Exclusion Criteria:
  • - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • - History or risk of autoimmune disease (i.e. SLE, RA, inflammatory bowel disease, Type
  • I DM, autoimmune thyroid disease, vasculitis, etc.)
  • - History of HIV, hepatitis B, or hepatitis C infection
  • - Any signs or symptoms of infection
  • - Malignancies other than disease under study within 5 years
  • - Prior allogeneic stem cell transplant
Interventions
Drug; MPDL3280A; Intravenous (IV) infusion repeating dose; [A]
Design Details
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Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
A Phase I, Open Label, Dose Escalation Study of the Safety and Pharmacokinetics of MPDL3280A Administered Intravenously As a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
Secondary Trial Identifying Number
GO27831
Website
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Study Funded By
Genentech, Inc.
Funder Type
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Study Sponsored By
Genentech, Inc.
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

16 Jun 2011

Last Updated

07 Apr 2014

Date Record Refreshed on UKCTG

31 Jul 2015