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Ref Type Journal Article
PMID (29905898)
Authors Weekes CD, Rosen LS, Capasso A, Wong KM, Ye W, Anderson M, McCall B, Fredrickson J, Wakshull E, Eppler S, Shon-Nguyen Q, Desai R, Huseni M, Hegde PS, Pourmohamad T, Rhee I, Bessudo A
Title Phase I study of the anti-α5β1 monoclonal antibody MINT1526A with or without bevacizumab in patients with advanced solid tumors.
Journal Cancer chemotherapy and pharmacology
Vol
Issue
Date 2018 Jun 15
URL
Abstract Text MINT1526A is a monoclonal antibody that blocks the interaction of integrin alpha 5 beta 1 (α5β1) with its extracellular matrix ligands. This phase I study evaluated the safety and pharmacokinetics of MINT1526A with or without bevacizumab in patients with advanced solid tumors.MINT1526A was administered every 3 weeks (Q3W) as monotherapy (arm 1) or in combination with bevacizumab 15 mg/kg, Q3W (arm 2). Each arm included a 3 + 3 dose-escalation stage and a dose-expansion stage.Twenty-four patients were enrolled in arm 1 (dose range 2-30 mg/kg) and 30 patients were enrolled in arm 2 (dose range 3-15 mg/kg). Monocyte α5β1 receptor occupancy was saturated at a dose of 15 mg/kg. No dose-limiting toxicities were observed, and the maximum tolerated dose was not reached in either arm. The most common adverse events, regardless of causality, included abdominal pain (25%), diarrhea (25%), nausea (21%), vomiting (21%), and fatigue (21%) in arm 1 and nausea (40%), fatigue (33%), vomiting (30%), dehydration (30%), headache (30%), and hypertension (30%) in arm 2. No grade ≥ 3 bleeding events were observed in either arm. No confirmed partial responses (PR) were observed in arm 1. In arm 2, one patient with thymic carcinoma experienced a confirmed PR and two patients with hepatocellular carcinoma (HCC) experienced durable minor radiographic responses.MINT1526A, with or without bevacizumab, was well-tolerated. Preliminary evidence of combination efficacy, including in patients with HCC, was observed, but cannot be distinguished from bevacizumab monotherapy in this phase I study.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
MINT1526A MINT1526A is a monoclonal antibody against integrin alpha 5 beta 1 that blocks interaction with extracellular matrix thus potentially leads to tumor cell death (PMID: 29905898).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown thymic carcinoma not applicable Bevacizumab + MINT1526A Phase I Actionable In a Phase I trial, MINT1526A in combination with Avastin (bevacizumab) resulted in partial response in a patient with thymic carcinoma (PMID: 29905898). 29905898
Unknown unknown Advanced Solid Tumor not applicable Bevacizumab + MINT1526A Phase I Actionable In a Phase I trial, MINT1526A in combination with Avastin (bevacizumab) resulted in 1 partial response and 2 durable minor radiographic responses in a total of 30 patients with advanced solid tumors (PMID: 29905898). 29905898
Unknown unknown Advanced Solid Tumor no benefit MINT1526A Phase I Actionable In a Phase I trial, MINT1526A monotherapy did not result in partial response in patients with advanced solid tumors (PMID: 29905898). 29905898
Unknown unknown hepatocellular carcinoma not applicable Bevacizumab + MINT1526A Phase I Actionable In a Phase I trial, MINT1526A in combination with Avastin (bevacizumab) resulted in durable minor radiographic responses in 2 patients with hepatocellular carcinoma (PMID: 29905898). 29905898