A Phase 1/2, Dose Escalation and Expansion Trial to Evaluate the Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma
HonorHealth Research Institute
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).
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. P…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent form (ICF) 2. Male or female, 18 years of age or older 3. Histologically and/or cytologically documented metastatic colorectal adenocarcinoma (all other histological types are excluded) a. RAS, BRAF, and MSI/ dMMR (Mismatch repair deficiency) status for each patient must be documented. 4. Disease progression or intolerance to ≥ 2 lines of systemic therapy for advanced/metastatic disease, including the following prior therapies unless contraindicated: fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens, an anti-vascular endothelial g…
Interventions
- DrugTegavivint
Tegavivint is a first-in-class chemical inhibitor that interferes with the binding of Transducin beta-like protein 1 (TBL1) to beta-catenin.
Location
- Clinical Trials Nurse NavigatorScottsdale, Arizona