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

DRUG

Tegavivint

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

DRUG

Lenvatinib

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 .

DRUG

Cabozantinib

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

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.

Adverse events will be assessed according to the NCI-CTCAE version 5.0

Number of participants with dose limiting toxicities

Time frame: Within a 28-day period after first dose of the study medication as a single agent or in combination with cabozantinib or lenvatinib.

Dose limiting toxicities defined as a Grade 3 or greater adverse event as assessed by NCI-CTCAE version 5.0 (excluding toxicities clearly related to the underlying disease \[HCC\], disease progression, concomitant medications, or baseline concurrent medical conditions),and that meets any of the criteria included in Table 6-5.

Evaluate efficacy of tegavivint as a single agent

Time frame: Tumors will be assessed at baseline and every 8 weeks until end of treatment, an average of 1 year

Evaluate efficacy of tegavivint as a single agent in subjects with hepatocellular carcinoma as assessed by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.