First-in-Human Study of PF-06647020 (Cofetuzumab) in Patients with Advanced Solid Tumors

Study Design and Treatment

This phase I, open-label, multi-center, nonrandomized study aimed to evaluate PF-06647020 in patients with advanced solid tumors. The primary objectives were to assess safety, tolerability, determine the MTD, and select the RP2D. Secondary objectives included pharmacokinetic profiles, immunogenicity, and antitumor activity evaluation.

Patients

Eligible patients were adults with locally advanced or metastatic solid tumors resistant to standard therapy or with no available standard therapy. They had adequate bone marrow, renal, liver, and cardiac function. Patients with measurable disease by RECIST v1.1 were included, with specific criteria for NSCLC, TNBC, and ovarian cancer patients.

Results

A total of 112 patients received PF-06647020 every 3 weeks, and 25 patients were treated every 2 weeks. The study found that the MTD for every 3 weeks administration was estimated at 2.8 mg/kg. The most common treatment-related adverse events (TRAEs) included nausea, alopecia, fatigue, headache, neutropenia, and vomiting. The study concluded that PF-06647020 was generally tolerable with a manageable safety profile.

Pharmacokinetics

Pharmacokinetic analyses showed that systemic exposure increased in a dose-related manner. The study also investigated the potential CYP3A-mediated drug-drug interaction with fluconazole, finding no notable impact on the overall exposure of PF-06380101 or PF-06647020.

This study provides foundational data on the safety, tolerability, and pharmacokinetics of PF-06647020, supporting further investigation into its therapeutic potential for advanced solid tumors.