RecruitingEarly Phase 1NCT07505771
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
Sponsor
Immunome, Inc.
Enrollment
105 participants
Start Date
Apr 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- ≥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 Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUG177Lu-IM-3050
177Lu-IM-3050 is a FAP-directed radiopharmaceutical
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07505771
Related Trials
A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
NCT0682316713 locations
A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
NCT0672538115 locations
A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies
NCT066007896 locations
Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors
NCT069330691 location
PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors
NCT066840281 location