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New treatment option for Relapsed / Refractory Osteosarcoma
Official title Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
ClinicalTrials.gov ID: NCT07357519
What this study is testing
What is LNTH2403 Phase 1 dose?
LNTH2403 Phase 1 dose is an investigational medicine, being studied as a potential treatment for relapsed / refractory osteosarcoma.
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
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- Measurable as defined in RECIST 1.1
- Evaluable non-measurable disease as per RECIST 1.1
You likely can't join if
- Participants meeting any of the following criteria will be excluded from the study
- Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the...
- Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy
- Known active infection
- Participation in an treatment study of another investigational agent
See the full eligibility 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).
- Measurable as defined in RECIST 1.1
- Evaluable non-measurable disease as per RECIST 1.1
- Bone only without a soft tissue component: must be 18F-FDG-PET avid and evaluable by serial 18F-FDG-PET imaging studies.
- 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...
- Performance Status:
- Eastern Cooperative Oncology Group (ECOG) Performance Score (PS): 0 - 2
- Lansky PS ≥ 50.
- 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...
- Participants meeting any of the following criteria will be excluded from the study
- Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients
- 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...
- Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy
- Known active infection
- Participation in an treatment study of another investigational agent
- Prior therapies or diagnostics
- Active prior or concurrent malignancy: immunoglobulin),
- Known active liver disease from any cause, Hepatitis A Virus
- Known to be human immunodeficiency virus (HIV) positive
- Clinically relevant cardiovascular disease
- Receipt of live vaccine within the 30 days prior to the first dose o
- A female participant who is pregnant or breastfeeding
- Major surgical procedure within 28 days of the first dose of LNTH-2403.
- Participant is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, 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.