trabedersen (OT-101)

P1/2, N=45, Recruiting, University of Nebraska | Not yet recruiting --> Recruiting

These results demonstrate the importance of TGFB2 as both a prognostic biomarker and therapeutic target in younger PDAC patients and further suggest that epigenetic modulation plays a key role in TGF-β signaling in pancreatic cancer progression. Our study emphasizes the isoform- and age-specific prognostic significance of TGFB2 in PDAC and supports the potential insights provided through methylation and expression profiling for personalized treatment strategies, particularly for younger patients who may benefit most from TGFB2-targeted therapies.

P1/2, N=45, Not yet recruiting, University of Nebraska | Trial completion date: Dec 2029 --> Feb 2029

P1/2, N=45, Not yet recruiting, University of Nebraska

P2/3, N=455, Recruiting, Oncotelic Inc. | Not yet recruiting --> Recruiting

P2, N=63, Not yet recruiting, Oncotelic Inc. | Trial completion date: Dec 2026 --> Dec 2029 | Trial primary completion date: Dec 2025 --> Dec 2028

P2/3, N=455, Not yet recruiting, Oncotelic Inc. | Phase classification: P2b --> P2/3 | Initiation date: Dec 2023 --> May 2024

P2b, N=468, Not yet recruiting, Oncotelic Inc.

P2, N=0, Withdrawn, University of Washington | N=30 --> 0 | Not yet recruiting --> Withdrawn

P2, N=30, Not yet recruiting, University of Washington

Multiple doses of OT-101 will be administered after completion of radiation therapy as intrathecal bolus injections. The study is designed to determine: 1) the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of OT-101, and 2) its efficacy in children with DIPG.