A 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

Genentech

Status and phase

Completed

Phase 1

Conditions

Solid Cancers

Treatments

Drug: bevacizumab

Drug: MINT1526A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01139723

GO00808 (Other Identifier)

MNT4863g

Details and patient eligibility

About

This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A administered alone and in combination with bevacizumab by IV infusion every 3 weeks to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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