RecruitingPhase 1NCT07144254

Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma

Study of Tegavivint, a Transducin Beta-like Protein 1 (TBL1) Inhibitor, With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma


Sponsor

Emory University

Enrollment

24 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to define the maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D) of Tegavivint in combination with Gemcitabine in patients with relapsed or refractory osteosarcoma (OS). The study will also investigate the toxicities of Tegavivint in combination with gemcitabine in patients with relapsed or refractory OS.


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — tegavivint and gemcitabine — in children, teens, and young adults with osteosarcoma (a type of bone cancer) that has come back or has not responded to prior treatment. It aims to find the right dose and assess the treatment's safety and effectiveness. **You may be eligible if...** - You have a confirmed diagnosis of osteosarcoma that has relapsed or is refractory - You previously received front-line chemotherapy including at least 3 of these drugs: methotrexate, doxorubicin, cisplatin, and ifosfamide - Your heart, liver, kidney, and bone marrow function are adequate - Your performance status (ability to function) meets requirements - You have measurable or evaluable disease **You may NOT be eligible if...** - You have active brain involvement from osteosarcoma - You are pregnant or breastfeeding - You are currently taking another experimental drug or anti-cancer treatment - You have received tegavivint before - You have received bisphosphonates within 4 weeks or denosumab within 6 months of enrollment - You have a known metabolic bone disorder - You have significant low calcium that does not improve with supplements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTegavivint

Tegavivint will be administered second, IV over 4 hours, on days 1, 8, and 15 at the dose level assigned at study entry Cycle length will be 21 days. A cycle may be repeated for a total of 17 cycles, up to a total duration of therapy of approximately 12 months.

DRUGGemcitabine

Gemcitabine will be administered first, intravenously (IV) over 60 minutes, on days 1 and 8 at a fixed dose of 1000 mg/m2


Locations(1)

Arthur M. Blank Children's Healthcare of Atlanta

Atlanta, Georgia, United States

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NCT07144254


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