Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07144254
Phase
PHASE1
Status
Recruiting
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Conditions

  • Osteosarcoma Recurrent
  • Osteosarcoma in Children
  • Refractory Osteosarcoma
  • Relapsed Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 22, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tegavivint with Gemcitabine
    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)

Primary Outcome Measure

Maximum dose tolerated [ Time Frame: upto day 21 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arthur M. Blank Children's Healthcare of AtlantaAtlantaGeorgia30322
Thomas Cash, MD
[email protected]
Thomas Cash, MD (PRINCIPAL_INVESTIGATOR)
Jsson Yustein, MD (SUB_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Arthur M. Blank Children's Healthcare of Atlanta· Atlanta, GA

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