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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solid Cancers

Intervention / Treatment
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* Drug: MINT1526A
* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: MINT1526A<br>* Intravenous escalating dose<br>|
| Experimental: B<br> | Drug: MINT1526A<br>* Intravenous escalating dose<br>Drug: bevacizumab<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of dose-limiting toxicities (DLTs) |  | Days 1 to 21 of cycle 1 | 
| Incidence, nature, and severity of adverse events and serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0 |  | Day 1 to study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of MINT1526A (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state) |  | Following administration of study drug |