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
Trial Purpose and Description
- To evaluate the safety and tolerability of MPDL3280A administered by intravenous (IV) infusion every 3 weeks (q3w) to patients with locally advanced or metastatic solid tumors
- To determine the maximum tolerated dose (MTD) and to evaluate the dose-limiting toxicities (DLTs) of MPDL3280A when administered as a single agent to patients by IV infusion q3w
- To identify a recommended Phase II dose of MPDL3280A
- 18 Years and older
- Age >18 years
- Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy
- Measurable disease per RECIST v1.1 for patients with solid malignancies.
- Adequate hematologic (not applicable for patients with AML, except for WBC and
platelet counts) and end organ function.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- INR and aPTT < 1.5 x ULN- This applies only to patients who do not receive therapeutic anticoagulation
patients receiving therapeutic anticoagulation should be on a stable dose.
- Any approved anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment.
- AEs from prior anti-cancer therapy that have not resolved to Grade < 1 except for alopecia
- Bisphosphonate therapy for symptomatic hypercalcemia
- Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed.
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease.
- Patients with acute promylocytic leukemias (FAB M3 or M3v), accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.
- Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases (> 2 lesions or requiring corticosteroids for symptomatic control).
- Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
- Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1
- Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.
- Genentech, Inc.
- Last Updated:
- Study HIC#: