177Lu-IM-3050, a targeted radiopharmaceutical for advanced solid tumors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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 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 2 years and approved by the Medical Monitor.

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 it's running

• XCancer Research Network / Dothan Hematology & Oncology
  Dothan, Alabama, United States Recruiting
• Stanford University School of Medicine
  Palo Alto, California, United States Recruiting
• NovaCure LLC
  Miami, Florida, United States Recruiting
• University of Texas - MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Excel Diagnostics and Nuclear Oncology Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Immunome Medical Monitor
• Email: info@immunome.com
• Phone: 425.939.7410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.