Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
HonorHealth Research Institute
Study ID
NCT07463599
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Feb 17, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
126 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - Tegavivint Monotherapy Dose Escalation
    Limited tegavivint monotherapy dose escalation using a Bayesian optimal interval (BOIN) design, starting at 6.5 mg/kg intravenously (IV) (weekly on day 1, 8, 15, and 22 of a 28-day cycle) to determine the MTD and/or RP2D. Dosing may be de-escalated to 5 mg/kg or escalated to 8 or 10 mg/kg dependent on isotonic regression of DLT rates across all dose levels.
  • Experimental: Part 2 - Tegavivint Monotherapy Phase 2 Dose Expansion
    Expansion cohort receiving tegavivint monotherapy at RP2D determined in Part 1 dose escalation to assess the safety profile and preliminary efficacy of tegavivint monotherapy using the Bayesian Optimal Phase 2 (BOP2) design.
  • Experimental: Part 3 - Arm A: Combination Dose Escalation of Tegavivint + Standard of Care Treatment
  • Experimental: Part 4 - Arm A: Tegavivint + Stand of Care Expansion
  • Experimental: Part 3 - Arm B: Tegavivint + Stand of Care Escalation
  • Experimental: Part 4 - Arm B: Tegavivint + Standard of Care Dose Expansion

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: ~24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Trials Nurse NavigatorScottsdaleArizona85258
Clinical Trials Nurse Navigator
[email protected]
833-354-6667
Carol Carol Guarnieri, RN, MSN, FNP-BC (PRINCIPAL_INVESTIGATOR)

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