Clinical Trial Details

Primary Objective:

1. To define the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of tegavivint in combination with gemcitabine in patients with relapsed or refractory OS
2. To define and describe the toxicities of tegavivint in combination with gemcitabine in patients with relapsed or refractory OS

Secondary Objectives:

1. To preliminarily determine the antitumor effects as measured by disease control (complete response, partial response, or stable disease) at 4 months of tegavivint in combination with gemcitabine in patients with relapsed or refractory OS within the confines of a phase 1b trial
2. To characterize the pharmacokinetics (PK) of tegavivint in combination with gemcitabine in patients with relapsed or refractory OS
3. To describe the progression-free survival, overall survival, and objective response rate

Exploratory Objectives:

1. To correlate baseline activity of the TBL1 and Wnt/beta-catenin pathway via mutational and genomic sequencing in tumor tissue, and detection of nuclear protein levels via IHC in tumor tissue, with clinical activity
2. To describe the pharmacodynamic activity of Wnt signaling and immune response proteins in peripheral blood in response to treatment
3. To explore ctDNA and circulating tumor cells (CTCs) as biomarkers of response