NCT07505771 · Immunome, Inc.
A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer
What this study is about
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
View original scientific description
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations