Actively Recruiting
A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies
Led by Immunome, Inc. · Updated on 2026-04-06
105
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 177Lu-IM-3050, a radiopharmaceutical targeting FAP-expressing advanced solid tumors, in a Phase 1 open-label study. This first-in-human trial aims to determine the safety, tolerability, dosimetry, pharmacokinetics, and early anti-tumor effects of this treatment in participants with advanced cancers who have relapsed or are refractory to prior therapies. The study has two parts: Part A is a dose escalation phase where increasing doses of 177Lu-IM-3050 are given intravenously every 6 weeks to identify the maximum tolerated dose or recommended dose for expansion. Part B is an expansion phase to further assess safety and tolerability at the selected dose. Participants receive the treatment in cycles lasting 6 weeks each, with up to three cycles planned or until discontinuation. Participants will undergo regular assessments including imaging scans to measure tumor response, blood tests to track drug levels and radiation exposure, and monitoring for treatment side effects from the first dose through at least 42 days after the final dose, with some safety follow-up extending up to 5 years. Researchers will evaluate safety events, dosing recommendations, and preliminary anti-tumor activity during the study period.
CONDITIONS
Brief Title
A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
- Histological or cytological diagnosis of a solid tumor
- Refractory to or relapsed after at least one prior standard therapy
- Measurable disease according to RECIST v.1.1 imaging criteria
- Positive FAP PET/CT uptake during screening
- Adequate organ function
You will not qualify if you...
- Received certain prior radiation therapy as specified in the protocol
- Major surgery within 4 weeks or minor surgery within 2 weeks before starting treatment
- Known active central nervous system primary tumor, metastases, or carcinomatous meningitis
- History of malignant primary brain tumor or other primary solid or hematologic malignancy unless disease-free for at least 3 years
- Recent or ongoing serious infection or significant medical condition
- Treatment with investigational product or device within 30 days or 5 half-lives before study treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 6-week cycles until disease progression or participant discontinuation
Participants receive intravenous 177Lu-IM-3050 on a 6-week cycle to evaluate safety, tolerability, pharmacokinetics, dosimetry, and preliminary anti-tumor activity.
1 visit every 6 weeks for treatment administration
Duration - At least 42 days to approximately 5 years after last treatment dose
Participants are monitored for safety and treatment effects for at least 42 days following the last dose and up to approximately 5 years.
Periodic visits during follow-up as scheduled by the study
Trial Site Locations
Total: 1 location
1
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here