Trabedersen (AP 12009) in the treatment of patients with advanced tumors: Completion of dose-escalation and first efficacy data.

2611 Background: Trabedersen (AP 12009) is a TGF-β2-specific antisense oligonucleotide. In a randomized and active-controlled phase IIb study in high-grade glioma patients, a clear survival benefit for trabedersen treatment over standard chemotherapy was found. In this study we evaluate the maximum tolerated dose (MTD), safety, pharmakokinetics, and efficacy of intravenous treatment with trabedersen in patients (pts) with other advanced solid tumors. Methods: In the open label, multicenter, dose-escalation phase I/II study, 33 pts with advanced pancreatic carcinoma (PancCa, stage IVA/IVB, N=23), malignant melanoma (stage III/IV, N=5), or colorectal carcinoma (stage III/IV, N=5) were enrolled in several cohorts. Pts were treated intravenously with trabedersen as 2nd to 4th-line therapy as monotherapy with escalating doses in 2 treatment schedules (1st schedule: 7d on, 7d off; 2nd schedule: 4d on, 10d off; up to 10 cycles). Results: Trabedersen showed high safety and tolerability. The only expected adverse ...