NCT07463599

Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma

A Phase 1/2, Dose Escalation and Expansion Trial to Evaluate the Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: HonorHealth Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the safety, tolerability, and preliminary efficacy of tegavivint as monotherapy (single) and in combination with standard therapies in patients with metastatic colorectal carcinoma (mCRC).

Detailed description

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.

Conditions

• Metastatic Colorectal Carcinoma (mCRC)
• Colorectal Cancer (CRC)
• Adenomatous Polyposis Coli (APC) Gene Mutation
• Catenin Beta-1 (CTNNB1) Gene Mutation

Interventions

Type	Name	Description
DRUG	Tegavivint	Tegavivint is a first-in-class chemical inhibitor that interferes with the binding of Transducin beta-like protein 1 (TBL1) to beta-catenin.

Timeline

• Start date: 2026-02-17
• Primary completion: 2029-01-01
• Completion: 2029-07-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study