A Phase 1 Study Of 177Lu-IM-3050 In Participants With Advanced Cancer

Overview

About this study

IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ajit Goenka, M.D.

Contact us for the latest status

Contact information:

Alicia Meek

5074229699

meek.alicia@mayo.edu

More information

Publications

Publications are currently not available