A Phase 1 interventional study of 177Lu-IM-3050 in Solid Malignancies, sponsored by Immunome, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Immunome, Inc. · Phase 1, Interventional, and Treatment
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
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.
Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening.
Exclusion Criteria:
Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.
177Lu-IM-3050 administered intravenously on a 6-week cycle
Drug: 177Lu-IM-3050
177Lu-IM-3050 administered intravenously on a 6-week cycle
Drug: 177Lu-IM-3050
177Lu-IM-3050 is a FAP-directed radiopharmaceutical
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 6.0, 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; 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 6.0, 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; up to approximately 5 years
Time course of blood radioactivity of 177Lu-IM-3050
Pharmacokinetic (PK) parameter: Area Under the Concentration Time Curve \[AUC\] in blood
Time frame: Through 42-49 days following last dose of 177Lu-IM-3050
Time course of blood radioactivity of 177Lu-IM-3050
Pharmacokinetic (PK) parameter: Maximum Concentration \[Cmax\] in blood
Time frame: Through 42-49 days following last dose of 177Lu-IM-3050
Time course of plasma IM-3050
PK parameter: Area Under the Concentration Time Curve \[AUC\] in blood
Time frame: Through 42-49 days following last dose of 177Lu-IM-3050
Time course of plasma IM-3050
PK parameter: Maximum Concentration \[Cmax\] in blood
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
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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
Complete response rate (CRR) as measured by RECIST v1.1
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
Disease control rate (DCR) as measured by RECIST v1.1
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 activity curves in the organs (e.g., kidneys) and tumor lesions
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
Absorbed dose calculations based on time activity courses in organs and tumor lesions
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
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE v6.0, including SAEs
Time frame: From dose of FAP PET/CT imaging tracer until end of study
Plan to share: Undecided
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Immunome, Inc.