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Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07144254•Emory University

View on ClinicalTrials.gov

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.

Detailed Description

Recurrent osteosarcoma (OS) has a poor prognosis, with 5-year overall survival after relapse ranging from 13% to 45%. There are currently no chemotherapy agents proven to significantly improve survival in relapsed or refractory OS, particularly in patients with unresectable disease, highlighting the need for new treatments. Tegavivint is a first-in-class small molecule that targets the Wnt/beta-catenin signaling pathway by inhibiting the TBL1-beta-catenin complex, leading to beta-catenin degradation and suppression of oncogenic transcription without affecting its normal cellular functions. Tegavivint showed potent anti-tumor activity in OS cell lines and mouse models, inhibiting tumor growth and metastasis, including activity against chemoresistant and cancer stem-like cells. Recent clinical data shows: Adults: In a Phase 1/2a trial (NCT03459469) with 24 patients, tegavivint at 5 mg/kg (3 weeks on/1 week off) was well tolerated with no dose-limiting toxicities. Most side effects were mild (fatigue, nausea, headache), and serious toxicities common to other Wnt inhibitors were not seen. Tumor shrinkage (\>50%) occurred in five patients, with others achieving prolonged stable disease. Pediatrics: In an ongoing COG Phase 1/2 trial (NCT04851119), tegavivint was tested in 10 patients at 5 and 6.5 mg/kg. No DLTs were observed, and the recommended dose was set at 6.5 mg/kg. Most side effects were grade 1-2; grade ≥3 events were infrequent.

Eligibility

Age

1 - 30 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis:
•Participants must have had histologic verification of osteosarcoma at original diagnosis or relapse.
•All participants with relapsed or refractory osteosarcoma are eligible, provided they received front-line treatment with a regimen that contained at least 3 of the following agents: methotrexate, doxorubicin, cisplatin, and ifosfamide
•-Disease Status:

Exclusion Criteria

•Dose Expansion: Participants with measurable or evaluable disease per RECIST and those with no evidence of disease on imaging following pulmonary metastasectomy are eligible during the dose expansion phase.
•-Performance Level: Participants must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of ≥ 60, or Eastern Cooperative Oncology Group (ECOG) ≤ 2 Note: Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory to assess the performance score.
•-Prior Therapy: Participants must have fully recovered from the clinically significant acute effects of all prior anti-cancer chemotherapy, immunotherapy, surgery, or radiation therapy before enrollment.
•Myelosuppressive chemotherapy: ≥ 14 days after the last dose.
•Hematopoietic growth factors: ≥ 14 days after a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for a short-acting growth factor. For agents with known delayed adverse events, extend recovery period accordingly.
•Biologic (anti-neoplastic) agent: ≥ 7 days after the last dose. Extend period if adverse events occur beyond 7 days.
•Cellular therapy: ≥ 21 days since last dose (e.g., modified T cells, gamma-delta T cells, natural killer (NK) cells, dendritic cells) with recovery from associated toxicities.
•Interleukins, interferons, and cytokines (excluding hematopoietic growth factors): ≥ 21 days since last dose.
•Antibodies: 7 days or 3 half-lives (whichever is longer), up to 30 days. Toxicity must be resolved to Grade ≤ 1.
•Radiation therapy (XRT):
+23 more criteria

Locations (1)

Arthur M. Blank Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Key Dates

Start Date

January 22, 2026

Primary Completion Date

May 1, 2028

Completion Date

May 1, 2028

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Osteosarcoma RecurrentOsteosarcoma in ChildrenRelapsed OsteosarcomaRefractory Osteosarcoma

Interventions

Tegavivint

DRUG

Gemcitabine

DRUG

Contacts

Kate Glasscox, BSN, RN

CONTACT

404-785-0002 aflacdevtreferral@choa.org

Lauren Johnson

CONTACT

3D Printed Personalized Extendable Prosthesis

NCT05794594

Osteosarcoma in Children

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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