A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies
Immunome, Inc.
Summary
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
Description
IM-3050-101 is a 2-part Phase 1 first-in-human (FIH), open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, dosimetry, pharmacokinetics (PK), and preliminary anti-tumor activity of the radiopharmaceutical 177Lu-IM-3050 in participants with FAP-expressing advanced solid tumors. Part A of the study is a dose escalation phase to evaluate the safety, tolerability, preliminary anti-tumor activity, radiation dosimetry, and PK from escalating repeated doses of 177Lu-IM-3050 to determine maximum tolerated dose (MTD) and/or recommended expansion dos…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥18 years of age * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2 * Histological or cytological diagnosis of a solid tumor * Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit. * Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening. * During screening, participants must have positive F…
Interventions
- Drug177Lu-IM-3050
177Lu-IM-3050 is a FAP-directed radiopharmaceutical
Location
- Excel Diagnostics and Nuclear Oncology CenterHouston, Texas