211At-MABG for Neuroendocrine Tumors

AC
Overseen ByAbramson Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Phase I dose escalation study of 211At-MABG in adults with advanced pheochromocytoma / paraganglioma (PPGL) or other NET-overexpressing cancers (as evidenced by positive MIBG imaging) who are refractory to, lacking, or ineligible for approved treatments. Phase 1 dose-escalation will follow a standard 3+3 design with an expansion cohort at the recommended phase two dose (RP2D).

Who Is on the Research Team?

VN

Vivek Narayan, MD, MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults with advanced neuroendocrine cancers, such as pheochromocytoma, paraganglioma, or medullary thyroid cancer. Participants must have tumors that show up on MIBG scans and either not respond to, lack access to, or can't receive standard treatments.

Inclusion Criteria

Life expectancy at least 3 months as judged by treating physician
I MIBG imaging indicating MIBG-avid disease (radiotracer uptake above background in at least one tumor site) per Investigator/Sub-Investigator assessment
Participants must provide written informed consent prior to study-specific procedures
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Exclusion Criteria

Serious or unstable medical, psychological, or social conditions that would compromise the subject's safety or successful participation in the study
I have not had anticancer treatment (except hormones or bone support) in the last 14 days.
I am able to tolerate all study procedures as judged by my doctor.
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What Are the Treatments Tested in This Trial?

Interventions

  • 211At-MABG

Trial Overview

Researchers are testing different doses of a new radioactive drug called 211At-MABG given in fractions to see what dose is safest and best tolerated in people with these cancers. The study uses a step-by-step approach where small groups get increasing doses.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Dose Level 2: Fractionated 211At-MABGExperimental Treatment1 Intervention
Group II: Dose Level 1: Fractionated 211At-MABGExperimental Treatment1 Intervention
Group III: Dose Level -1: Fractionated 211At-MABGExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+