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New treatment option for Osteosarcoma Recurrent
Official title Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
ClinicalTrials.gov ID: NCT07144254
What this study is testing
What is Tegavivint?
Tegavivint is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for osteosarcoma recurrent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join if
- 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...
- Dose Escalation: Participants must have either measurable or evaluable disease per RECIST.Note: Participants with no evidence of disease on imaging...
- Dose Expansion: Participants with measurable or evaluable disease per RECIST and those with no evidence of disease on imaging following pulmonary...
- Myelosuppressive chemotherapy: ≥ 14 days after the last dose.
You likely can't join if
- CNS disease: Patients with a history of intraparenchymal CNS disease (osteosarcoma) are not eligible unless they have imaging documenting stability...
- 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...
- Concomitant Medications:
- Investigational Drugs: people who are currently receiving another investigational drug are not eligible.
See the full eligibility criteria
Who can join
- 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...
- 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 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...
- 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...
- 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...
- 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
What rules you out
- 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: people who are currently receiving another investigational drug are not eligible.
- Anti-cancer Agents: people 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...
- 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: people who have an active, uncontrolled infection.
- people who have received prior solid organ or allogeneic stem cell transplantation.
- people 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...
- Patients who have previously received tegavivint are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.