Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)
ConditionRelapsed / Refractory Osteosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorLantheus Medical Imaging
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 the study, or otherwise impair the assessment of study results
Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy
Known active infection
Trial design
Treatments tested in this trial
- LNTH2403 Phase 1 dose
- Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).
Treatment groups
55 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov