A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer

A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies

IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.

Study Overview

• Status: Recruiting
• Conditions: Solid Malignancies
• Intervention / Treatment: Drug: 177Lu-IM-3050

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77042
      • Recruiting
      • Excel Diagnostics and Nuclear Oncology Center
      • Contact: Ebrahim Delpassand, MD; Phone Number: 713-781-6200; Email: edelpassand@exceldiagnostics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 FAP PET/CT uptake as described in criteria for continuation of IM-3050 treatment.
• Participants must have adequate organ function.

Exclusion Criteria:

• Participant has received certain prior radiation therapy as detailed in the protocol
• Participant has undergone major surgery within 4 weeks or minor surgery within 2 weeks of starting 177Lu-IM-3050 or has known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis.
• Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 3 years.

Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.

• Recent or ongoing serious infection or other significant medical condition as detailed in the protocol.
• Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET/CT imaging tracer or 177Lu-IM-3050.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment and up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course of blood radioactivity of 177Lu-IM-3050	Pharmacokinetic (PK) parameter: Area Under the Concentration Time Curve [AUC] in blood	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	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	Through 42-49 days following last dose of 177Lu-IM-3050
Time course of plasma IM-3050	PK parameter: Maximum Concentration [Cmax] in blood	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	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	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	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	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	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 v5.0, including SAEs	From dose of FAP PET/CT imaging tracer to 72 hours after dose

Collaborators and Investigators

• Sponsor: Immunome, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IM-3050-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No