Experimental combo aims to tackle tough bone cancer
NCT ID NCT07144254
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new drug called tegavivint combined with the chemotherapy gemcitabine in 24 people whose osteosarcoma (a type of bone cancer) has returned or not responded to prior treatment. The main goal is to find the safest dose of tegavivint when given with gemcitabine, and to see if the combination can control the disease. Participants receive the drugs intravenously over several weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tegavivint and gemcitabine
- What this could lead to
- If successful, this could lead to a new treatment option for patients with osteosarcoma that has come back or not responded to standard therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, focused on finding a safe dose. It is not yet known if the combination will effectively control the cancer, and side effects may be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 30 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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 Prior use of Nucleoside Analogue (Gemcitabine): Allowed. Investigational agents not otherwise specified: ≥ 30 days since last dose. Surgery: ≥ 2 weeks since last major surgery, including pulmonary metastasectomy (central line placement and core/small open biopsies are excluded) Organ Function Requirements: * 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 Criteria: * 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Arthur M. Blank Children's Healthcare of Atlanta
RECRUITINGAtlanta, Georgia, 30322, United States
Contact Email: •••••@•••••
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