Tegavivint with Gemcitabine for Relapsed or Refractory Osteosarcoma
This study is testing a new combination treatment for osteosarcoma (a type of bone cancer) that has come back (relapsed) or hasn't responded to previous treatments (refractory). The treatment combines Tegavivint, a drug that targets a specific pathway in cancer cells, with Gemcitabine, a chemotherapy drug. The main goal is to find the highest safe dose of Tegavivint when given with Gemcitabine. You might be able to join if you are between 1 and 30 years old, have osteosarcoma that has relapsed or is refractory, and have received certain previous treatments. This study aims to find new ways to treat this challenging cancer.
- Study design
- This is an interventional study planning to enroll 24 participants. It is not specified if it is randomized or blinded.
- What's involved
- Tegavivint is given intravenously (into a vein) three times every 21 days, and Gemcitabine is given intravenously twice every 21 days. Treatment may last up to 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, maximum tolerated dose, is measured up to day 21. Further follow-up duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07144254
Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
Recruiting
PHASE1Ages 1–30InterventionalTreatmentEmory UniversityInvestigator-initiated
~24 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:TegavivintGemcitabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum dose tolerated
Measured over upto day 21
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- Thomas Cash, MD, MSc · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Dose Escalation: Participants must have either measurable or evaluable disease per RECIST.Note: Participants with no evidence of disease on imaging (e.g., following pulmonary metastasectomy) are not eligible during the dose escalation phase.
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):
14 days after local palliative XRT (small port)
150 days after radiation to ≥ 50% of pelvis or bone marrow
6 weeks after substantial bone marrow radiation
Adequate Bone Marrow Function Defined As:
Peripheral absolute neutrophil count (ANC) ≥ 750/mm3 (0.75x109/L)
Platelet count ≥ 75,000/mm3 (75x109/L)
Adequate Renal Function Defined As: Creatinine clearance or radioisotope GFR ≥ 70 ml/min/1.73 m2
Adequate Liver Function Defined As:
Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x the upper limit of normal (ULN) for age
ALT ≤ 5 x the ULN
Adequate Pulmonary Function Defined As: No dyspnea at rest, no exercise intolerance, and no oxygen requirement (pulse oximetry \> 93% on room air).
Adequate Cardiac Function Defined As: QTc ≤ 470 ms using Fridericia formula
Exclusion
CNS disease: Patients with a history of intraparenchymal CNS disease (osteosarcoma) are not eligible unless they have imaging documenting stability of CNS lesions for ≥ 3 months prior to enrollment
Pregnancy or Breast-Feeding
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Males or females of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method
Concomitant Medications:
Investigational Drugs: Subjects who are currently receiving another investigational drug are not eligible.
Anti-cancer Agents: Subjects who are currently receiving other anti-cancer agents are not eligible.
CYP3A4/5 Agents: Patients currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days before the 1st dose of tegavivint to the end of the study. See Appendix II for a list of agents.
Bisphosphonates: Patients receiving bisphosphonates within 4 Weeks of study enrollment are not eligible.
Denosumab: Patients who have received denosumab within 180 days prior to study enrollment are not eligible
Infection: Subjects who have an active, uncontrolled infection.
Subjects who have received prior solid organ or allogeneic stem cell transplantation.
Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia).
Patients with a disorder associated with abnormal bone metabolism.
Patients with ≥ 2 grade hypocalcemia that is not corrected with oral calcium supplementation.
Patients with vitamin D \< 20 ng/mL will require supplementation or will otherwise be excluded. Patients must agree to take vitamin D +/- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained.
Patients who have previously received tegavivint are not eligible.
What this trial measures
- Maximum dose toleratedupto day 21
The maximum tolerated dose (MTD) of Tegavivint administered intravenously over 4 hours on days 1, 8, and 15 at the dose level assigned at study entry in combination with gemcitabine. The MTD is empirically defined as the highest dose level at which no more than one patient is experiencing a dose-limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. The MTD will be determined during Cycle 1 (each cycle is 21 days)