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This is a multi-center, non-randomized, open-label, dosimetry and dose-escalation, cohort-expansion study of LNTH-2403 administered to subjects with relapsed / refractory (R/R) osteosarcoma. This study consists of 2 phases: (1) a dosimetry and dose escalation phase; and (2) a cohort expansion phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1- Escalating doses of LNTH-2403 administered once every 8 weeks | Experimental | Phase 1 will evaluate escalating doses of LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data. |
|
| Phase 2 will evaluate LNTH-2403 as a single agent at the recommended phase 2 dose | Experimental | Phase 2 will evaluate LNTH-2403 as a single agent in participants with R/R osteosarcoma at the recommended phase 2 dose (RP2D). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNTH2403 Phase 1 dose | Drug | LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data. |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the maximum tolerated dose (MTD) of LNTH-2403 in participants with R/R osteosarcoma (Ph1) | Incidence of DLTs during the first 8 weeks (DLT evaluation window) after the first dose of LNTH-2403 | From enrollment to the end of treatment at 8 weeks |
| To evaluate the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph1) | Type, frequency, severity, timing, and relationship to LNTH-2403 of all Treatment-emergent adverse event, (TEAEs) and Serious adverse events, (SAEs) | From enrollment to the end of treatment at 8 weeks |
| To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph2) | Event-Free Survival (EFS) at 4 months | From enrollment to Event-Free Survival (EFS) at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph1) | Event-Free Survival (EFS) at 8 weeks | 8 weeks |
| To describe the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph2) |
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Inclusion Criteria: Participants must meet all the following criteria to be enrolled in the study
Histopathologic documented diagnosis of R/R osteosarcoma
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).
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.
Performance Status:
Body weight: ≥ 30 kg.
Tumor biopsies; Fresh or Archival
Progression following at least one course of chemotherapy, which includes neoadjuvant / perioperative systemic therapy.
All adverse events (AEs) related to prior therapies (chemotherapy / systemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline
Organ Function
Pregnancy Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test result at screening
Contraception- Male participants with a WOCBP partner must use 2 forms of acceptable contraception
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerri Sforzo | Contact | 978-671-8886 | clinicaltrials@lantheus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D017322 | Clinical Trials, Phase II as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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Phase 1 will evaluate escalating doses of LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data.
Phase 2 will evaluate LNTH-2403 as a single agent in participants with R/R osteosarcoma at the recommended phase 2 dose (RP2D).
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| Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D). | Drug | Once the RP2D is selected, phase 2 will commence |
|
Type, frequency, severity, timing, and relationship to LNTH-2403 of any TEAEs and SAEs |
| 4 months |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |