A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma

Conditions

• Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tegavivint — DRUG
  The first part is a phase 1 single-agent dose escalation, optimization, and expansion study of tegavivint in patients with advanced HCC after failure of at least one line of prior systemic therapy. Tegavivint single agent dosing regimen: Tegavivint will be administered weekly on Days 1, 8, 15, and 22 of a 28-day cycle
• Lenvatinib — DRUG
  In the second part of the study, the combination of tegavivint plus lenvatinib will be assessed with a limited dose escalation followed by a randomized dose optimization. Tegavivint plus lenvatinib combination dosing regimen: Tegavivint will be administered weekly on Days 1, 8, and 15 and 22 of a 28-day cycle; lenvatinib 8 mg (patients \< 60 kg) or 12 mg (patients ≥ 60 kg) will be administered once daily on days 1-28 of a 28-day cycle .
• Cabozantinib — DRUG
  In the second part of the study, the combination of tegavivint plus cabozantinib will be assessed with a limited dose escalation followed by a randomized dose optimization. Tegavivint plus cabozantinib combination dosing regimen: Tegavivint will be administered weekly on Days 1, 8, and 15 and 22 of a 28-day cycle; cabozantinib 60 mg (patients with Child-Pugh A) or 40 mg (patients with Child-Pugh B) will be administered orally once daily on days 1 through 28 of each 28-day cycle

Study Details

This study will be conducted in 2 parts. The first part is a phase 1 single-agent dose escalation, and dose optimization, study of tegavivint in patients with advanced HCC after failure of at least one line of prior systemic therapy. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib) followed by a combination dose expansion.

Key Dates

Start date

Sep 13, 2023

Status verified

Jul 2025

Primary completion

May 31, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

178 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tegavivint single agent dosing regimen
  Tegavivint as monotherapy
• Experimental: Tegavivint plus cabozantinib combination dosing regimen
  Tegavivint in combination with cabozantinib
• Experimental: Tegavivint plus lenvatinib combination dosing regimen
  Tegavivint in combination with lenvatinib

Primary Outcome Measure

Incidence of Treatment-Related Adverse Events [ Time Frame: from the date of the first dose of study medication up to 90 days following last dose of study medication or initiation of new systemic anti-cancer therapy, whichever occurs first, an average of 1 year. ]

Central Contacts

• Rose Hernandez
  832-721-5208
  [email protected]
• Gilberto Botello
  [email protected]

Locations (7)

Find similar trials in Duarte, CA

Related Studies

• Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma
  PHASE2 · Recruiting · Mary Feng, MD · San Francisco, California
• Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease
  PHASE1 · Recruiting · University of Southern California · Los Angeles, California
• At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
  PHASE2 · Recruiting · Mayo Clinic · Jacksonville, Florida