A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies
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.
Detailed 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 dose of 177Lu-IM-3050. Part B of the study is an expansion phase to further evaluate safety and tolerability of 177Lu-IM-3050 at the candidate recommended dose.
Arms & interventions
- Drug177Lu-IM-3050
177Lu-IM-3050 is a FAP-directed radiopharmaceutical
Outcome measures
Primary
Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0, including adverse events (SAEs), AEs leading to discontinuation, and deaths
Time frame: From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious and up to approximately 5 years
Determine the recommended dose of 177Lu-IM-3050 for further development
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 5.0, including SAEs, AEs leading to discontinuation, and deaths
Time frame: From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment and up to approximately 5 years
Secondary
Time course of blood radioactivity of 177Lu-IM-3050
Time frame: Through 42-49 days following last dose of 177Lu-IM-3050
Time course of blood radioactivity of 177Lu-IM-3050
Time frame: Through 42-49 days following last dose of 177Lu-IM-3050
Time course of plasma IM-3050
Time frame: Through 42-49 days following last dose of 177Lu-IM-3050
Time course of plasma IM-3050
Time frame: Through 42-49 days following last dose of 177Lu-IM-3050
Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors
Time frame: Week 6 until disease progression or participant discontinuation from study
Evaluate the dosimetry of 177Lu-IM-3050 in participants with advanced solid tumors
Time frame: From first dose of 177Lu-IM-3050 3050 in Cycle 1 up to 8 days after Cycle 3 (each cycle is 42 days) or until participant discontinuation, whichever is earlier
Evaluate the dosimetry of 177Lu-IM-3050 in participants with advanced solid tumors
Time frame: From first dose of 177Lu-IM-3050 3050 in Cycle 1 up to 8 days after Cycle 3 (each cycle is 42 days) or until participant discontinuation, whichever is earlier
Safety and tolerability of FAP PET/CT imaging tracer in participants with advanced solid tumors as measured by incidence of TEAEs
Time frame: From dose of FAP PET/CT imaging tracer to 72 hours after dose
Eligibility criteria
Study locations (2)
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042