177Lu-PSMA for Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAna Kiess, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a single arm trial with one Cohort for people with recurrent or metastatic adenoid cystic carcinoma that cannot be treated with surgery. 10 participants will be enrolled in Cohort 1 at Johns Hopkins and will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). A feasibility analysis of dosimetry will be performed after meeting the accrual goal of Cohort 1 to determine if the study will proceed into Cohort 2. If Cohort 2 proceeds, based on the dosimetry analysis, the major requirements of the study are to undergo treatment with 177Lu-PNT2002, have bloodwork, physical exams, and imaging done at study-specific time points, and to answer questionnaires. Patients will be in the study for about two years after enrolling.

Eligibility Criteria

This trial is for people with recurrent or metastatic adenoid cystic carcinoma that's not suitable for surgery. Participants will be part of a study at Johns Hopkins, undergoing special imaging and possibly treatment with the drug 177Lu-PNT2002 if they move to Cohort 2 after initial assessments.

Inclusion Criteria

I can understand and am willing to sign the consent form.

My cancer, ACC, has been confirmed by a pathology review.

My ACC cancer has returned or spread and can't be removed by surgery or treated with radiotherapy.

+7 more

Exclusion Criteria

Patient receiving any other investigational agents

Any medical comorbidities that might preclude safe participation in the study

Refusal to sign informed consent

+5 more

Participant Groups

The trial is testing the use of a radioactive drug called 177Lu-PNT2002 in patients with specific cancer. Initially, participants undergo diagnostic imaging; if results are favorable, they may receive the actual treatment in Cohort 2.

1Treatment groups

Experimental Treatment

Group I: SPECT CT DosimetryExperimental Treatment1 Intervention

Absorbed dose in tumor and normal organs will by measured using SPECT/CT dosimetry in Cohort 1.