Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma

This multi-part Phase 1/2 trial dose escalation and expansion trial will evaluate tegavivint in patients with metastatic colorectal carcinoma (mCRC). The trial begins with Part 1, a monotherapy dose escalation using a Bayesian optimal interval (BOIN) design, starting at 6.5 mg/kg intravenously (IV) to determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D) (9-18 patients enrolled). Following the establishment of the monotherapy RP2D, Part 2 will enroll up to 24 patients in a Phase 2 expansion cohort to evaluate preliminary efficacy of tegavivint monotherapy in mCRC. Part 3 will conduct limited dose escalation of tegavivint in combination with two different standard of care therapy regimens. Each combination arm will follow a BOIN design to establish the combination RP2D. Upon determination of the combination RP2Ds, Part 4 will open two parallel Phase 2 expansion cohorts of up to 24 patients each to evaluate the preliminary efficacy of these combination regimens.