Tegavivint + Gemcitabine for Bone Cancer

Overseen By Kate Glasscox, BSN, RN

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Emory University

Must not be taking: CYP3A4 drugs, Bisphosphonates

Disqualifiers: CNS disease, Pregnancy, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: up to 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the optimal dose and safety of a new treatment that combines Tegavivint (an experimental treatment) and Gemcitabine (a chemotherapy drug) for individuals with osteosarcoma, a type of bone cancer that has returned or resisted previous treatments. The goal is to identify the most effective dose without severe side effects. Individuals whose osteosarcoma has recurred and who have already tried certain other cancer treatments may qualify for this trial. Participants must fully recover from any recent cancer treatments before joining. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications. You cannot be on other anti-cancer agents, investigational drugs, or drugs that strongly affect CYP3A4 enzymes. You also need to avoid bisphosphonates and denosumab for specific periods before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is testing the combination of Tegavivint and Gemcitabine to determine the optimal dose for treating relapsed or refractory osteosarcoma, a type of bone cancer. The main goal is to assess patient tolerance to this combination and identify any side effects.

Early studies indicate that researchers are still exploring potential side effects, focusing on patient responses and dose optimization. While researchers remain hopeful, more information is needed to fully understand the treatment's safety.

Gemcitabine, a chemotherapy drug already used for some cancers, has well-known side effects. However, combining it with Tegavivint is new, making this trial crucial for identifying any new or increased side effects from the combination.

Prospective participants should know that the treatment is still under study for safety and effectiveness. It is essential to discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of Tegavivint and Gemcitabine for bone cancer because it offers a fresh approach to treatment. Unlike typical chemotherapies, Tegavivint targets the Wnt/β-catenin signaling pathway, which plays a crucial role in cancer cell growth and survival. This makes it distinct from standard treatments like doxorubicin or methotrexate that don't specifically target this pathway. By pairing Tegavivint with Gemcitabine, there's potential to enhance the effectiveness of therapy while potentially reducing the cancer's resistance to treatment.

What evidence suggests that Tegavivint combined with Gemcitabine might be an effective treatment for osteosarcoma?

Research has shown that using Tegavivint with Gemcitabine might help treat osteosarcoma, a type of bone cancer. Tegavivint stops a protein that aids cancer cell growth, while Gemcitabine is a chemotherapy drug that kills cancer cells. Although limited information exists from human studies on this combination, early research suggests it might slow cancer spread or shrink tumors. In this trial, participants will receive Tegavivint with Gemcitabine to determine the highest dose patients can tolerate without severe side effects. This combination is under study because patients with recurring osteosarcoma currently face a poor outlook, with survival rates dropping significantly. ^{1 2 3 4 5}

Who Is on the Research Team?

Thomas Cash, MD, MSc

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients with osteosarcoma, a type of bone cancer, who have experienced a return or resistance to previous treatments. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have measurable disease that can be followed over the course of the study.

Inclusion Criteria

I can do most activities but may need help, or I am up and about more than half of my waking hours.

I have recovered from side effects of my previous cancer treatments.

I have osteosarcoma that came back or didn't respond to treatment, and I've been treated with at least 3 specific drugs.

Exclusion Criteria

Pregnancy or Breast-Feeding

Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

My low calcium levels haven't improved with oral supplements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tegavivint and Gemcitabine for up to 17 cycles, with dose escalation to determine the maximum tolerated dose

up to 12 months

Visits on days 1, 8, and 15 of each 21-day cycle

Follow-up

Participants are monitored for overall survival and progression-free survival

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Tegavivint

Trial Overview The trial is testing Tegavivint in combination with Gemcitabine to find out the highest dose patients can take without severe side effects (MTD) and/or the suggested dose for future Phase 2 trials (RP2D). It's focused on those whose osteosarcoma has come back or hasn't responded to treatment.

How Is the Trial Designed?

Group I: Tegavivint with Gemcitabine Experimental Treatment 2 Interventions

Subjects can receive treatment with tegavivint and gemcitabine for up to 17 cycles (1 cycle = 21 days). Treatment will be discontinued if there is progressive disease or toxicity requiring treatment discontinuation Dose Escalation: Dose level 0: Tegavivint = 3(mg/kg) and Gemcitabine 1000 (mg/m2) Dose level 1: Tegavivint = 5(mg/kg) and Gemcitabine 1000 (mg/m2) Dose level 2: Tegavivint = 6.5(mg/kg) and Gemcitabine 1000 (mg/m2)

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Iterion Therapeutics

Industry Sponsor

Trials

2

Recruited

130+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07144254

Tegavivint With Gemcitabine in Patients With Relapsed or ... Recurrent osteosarcoma (OS) has a poor prognosis, with 5-year overall survival after relapse ranging from 13% to 45%.

2. smartpatients.com smartpatients.com/trials/NCT07144254

Tegavivint With Gemcitabine in Patients With Relapsed or ... The study will also investigate the toxicities of Tegavivint in combination with gemcitabine in patients with relapsed or refractory OS.

3. withpower.com withpower.com/trial/phase-1-osteosarcoma-9-2025-858cb

Tegavivint + Gemcitabine for Bone Cancer Trial Overview The trial is testing Tegavivint in combination with Gemcitabine to find out the highest dose patients can take without severe side effects (MTD) ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT07144254

Tegavivint With Gemcitabine in Patients With Relapsed or ... Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma. P1. Emory University. N=24. Not yet recruiting. NA. Outcome Timelines (2).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8998815/

Recent and Ongoing Research into Metastatic ... Median survival for patients with unresectable metastases was 13 months and 31 months for those who underwent successful metastasectomy [37]. Trial data to date ...