177Lu-IM-3050, a targeted radiopharmaceutical for advanced solid tumors.
A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies
This trial will test whether the targeted radioactive drug 177Lu-IM-3050 is safe and can shrink FAP-positive advanced solid tumors in adults who have not responded to standard treatments.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Immunome, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07505771 on ClinicalTrials.gov |
What this trial studies
IM-3050-101 is a first-in-human, open-label Phase 1 trial with two parts: dose escalation to determine a maximum tolerated or recommended expansion dose and an expansion phase to further evaluate safety at that dose. It enrolls adults with measurable, FAP-expressing advanced solid tumors confirmed by FAP PET/CT who are relapsed or refractory to standard therapies. Participants receive repeated doses of the radiopharmaceutical 177Lu-IM-3050 and undergo safety monitoring, radiation dosimetry, pharmacokinetics sampling, and tumor imaging to capture preliminary anti-tumor activity. Collected data on tolerability, organ exposure, and tumor responses will guide dose selection and future trials.
Who should consider this trial
Good fit: Adults (≥18) with measurable, FAP PET/CT–positive advanced solid tumors, ECOG 0–2, who are relapsed or refractory to at least one standard therapy and have adequate organ function are the intended candidates.
Not a fit: Patients who lack FAP expression on PET/CT, have poor organ function, recent major surgery, certain prior radiation exposures, or uncontrolled central nervous system disease are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this approach could provide a new targeted radiopharmaceutical option that selectively delivers radiation to FAP-expressing tumor tissue and may reduce tumor burden in patients with advanced cancers.
How similar studies have performed: Early first-in-human studies of other FAP-targeted radioligand therapies have shown preliminary tumor responses in some patients but remain limited and exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- Excel Diagnostics and Nuclear Oncology Center — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.