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Phase 1 Study of 177Lu-IM-3050 for Advanced Solid Tumors

This is a Phase 1 study testing a new treatment called 177Lu-IM-3050 for people with advanced solid tumors (cancers that form solid masses). The main goals are to see how safe 177Lu-IM-3050 is and to find the best dose for future studies. You might be able to join if you are at least 18 years old, have a solid tumor that has either not responded to or has come back after at least one standard treatment, and have a good general health status (ECOG PS of 0, 1, or 2). The study is currently unclear on its recruitment status. Success in this study means finding a safe dose and understanding any side effects of 177Lu-IM-3050.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 105 participants and involves a dose escalation and expansion design.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first dose through at least 42 days after your last dose, and potentially for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07505771

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Immunome, Inc.
~105 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:177Lu-IM-3050

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
Measured over From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious; up to approximately 5 years
+1 more outcome measured

Conditions

Solid Malignancies

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Solid Neoplasm

NCT07505771

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Excel Diagnostics and Nuclear Oncology Center

    Houston, Texasno site contact published

    Recruiting

  • Stanford University School of Medicine

    Palo Alto, Californiano site contact published

    Recruiting

  • University of Texas - MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

  • XCancer Research Network / Dothan Hematology & Oncology

    Dothan, Alabamano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Immunome Medical Monitor
[email protected]
425.939.7410
Email the study team

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Eligibility criteria

Inclusion

≥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 Part A only, participants without measurable disease per RECIST v1.1 are eligible if approved by Medical Monitor.
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

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 2 years and approved by the Medical Monitor.
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.

What this trial measures

  • Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious; up to approximately 5 years

    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

  • Determine the recommended dose of 177Lu-IM-3050 for further developmentFrom first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment; up to approximately 5 years

    Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 6.0, including SAEs, AEs leading to discontinuation, and deaths