New radiation drug targets bone cancer cells directly
NCT ID NCT07357519
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called LNTH-2403, which delivers radiation directly to cancer cells in people with osteosarcoma (a type of bone cancer) that has returned or not responded to standard treatments. The drug is given as an injection and aims to shrink tumors or slow their growth. About 55 adults will take part to find the safest dose and see how well it works.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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12 years and older
- 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: Participants must meet all the following criteria to be enrolled in the study 1. Histopathologic documented diagnosis of R/R osteosarcoma 2. Must have disease characterized by at least one of the following (Participants meeting only (b.), only (c.), or only (b. and c.) must be discussed with and receive written approval from the Sponsor to qualify). 1. Measurable as defined in RECIST 1.1 2. Evaluable non-measurable disease as per RECIST 1.1 3. Bone only without a soft tissue component: must be 18F-FDG-PET avid and evaluable by serial 18F-FDG-PET imaging studies. 3. Age: a. First Cohort in Phase 1: ≥ 18 years-of-age at the time of signature of the main study ICF. b. Second and subsequent cohorts, in Phase 1 and all participants in Phase 2: ≥12years-of-age at the time of signature of the main ICF. 4. Performance Status: 1. Eastern Cooperative Oncology Group (ECOG) Performance Score (PS): 0 - 2 2. Lansky PS ≥ 50. 5. Body weight: ≥ 30 kg. 6. Tumor biopsies; Fresh or Archival 7. Progression following at least one course of chemotherapy, which includes neoadjuvant / perioperative systemic therapy. 8. All adverse events (AEs) related to prior therapies (chemotherapy / systemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline 9. Organ Function 10. Pregnancy Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test result at screening 11. Contraception- Male participants with a WOCBP partner must use 2 forms of acceptable contraception 12. Written informed consent and/or assent must be obtained according to local guidelines and signed and dated by the participant, parent, and/or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study 1. Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients 2. Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the participant's safety, compliance with the study, or otherwise impair the assessment of study results 3. Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy 4. Known active infection 5. Participation in an interventional study of another investigational agent 6. Prior therapies or diagnostics 7. Active prior or concurrent malignancy: immunoglobulin), 8. Known active liver disease from any cause, Hepatitis A Virus 9. Known to be human immunodeficiency virus (HIV) positive 10. Clinically relevant cardiovascular disease 11. Receipt of live vaccine within the 30 days prior to the first dose o 12. A female participant who is pregnant or breastfeeding 13. Major surgical procedure within 28 days of the first dose of LNTH-2403. 14. Participant is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions
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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
2 sites. 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
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
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UCLA
RECRUITINGLos Angeles, California, 90095, United States