A Phase I, Open Label, Dose Escalation Study of the Safety and Pharmacokinetics of MINT1526A, Administered Intravenously As a Single Agent and in Combination With Bevacizumab to Patients With Advanced Solid Tumors
Inclusion Criteria:
- Histologically or cytologically documented, incurable, or metastatic solid malignancy
that has progressed on or failed to respond to regimens or therapies known to provide
clinical benefit
- Adequate hematologic and end organ function
- Evaluable disease or measurable disease per Response Evaluation Criteria in Solid
Tumors (RECIST) 1.0; prostate cancer patients with nonevaluable or nonmeasurable
disease if they have an increase in prostate-specific antigen (PSA); ovarian cancer
patients with nonevaluable or nonmeasurable disease if they have an increase in
cancer antigen 125 (CA-125)
- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement to use an effective form of contraception and to
continue its use for 6 months after discontinuation from the study
Exclusion Criteria:
- Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy
within a specified timeframe prior to initiation of study treatment.
- Leptomeningeal disease
- Active infection requiring intravenous antibiotics
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory
drugs, inhaled corticosteroids, or prednisone
- Bisphosphonate therapy for symptomatic hypercalcemia
- Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis, or cirrhosis
- Known primary central nervous system (CNS) malignancy or untreated or active CNS
metastases
- Pregnancy, lactation, or breastfeeding