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?

This trial tests a new treatment called 211At-MABG, a type of targeted radiotherapy, for individuals with certain advanced neuroendocrine tumors unresponsive to traditional treatments. Researchers aim to assess the safety and effectiveness of 211At-MABG by experimenting with different dose levels. The trial seeks participants whose tumors absorb a specific tracer, which aids in tumor detection on imaging tests, and who have not found success with other available treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that 211At-MABG is likely to be safe for humans?

Previous studies have explored 211At-MABG in various contexts, revealing some potential benefits. Research suggests that it might offer survival benefits for glioblastoma, a type of brain cancer. However, this trial primarily focuses on its safety.

For neuroblastoma, a cancer originating in certain early nerve cells, studies have assessed the safety and patient tolerance of 211At-MABG. Although detailed safety data from these studies is limited, the continuation of clinical trials suggests it has been reasonably well-tolerated so far.

Like many treatments, 211At-MABG may have side effects, but specific details are not clearly provided in the sources. As this is an early-phase trial, the main goal is to assess safety and determine safe dosage levels, meaning the treatment is still under careful study to understand its safety.

Patients considering participation in such trials should consult their doctors to understand the potential risks and benefits based on the latest information.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for neuroendocrine tumors, which often include surgery, chemotherapy, and radiation, the investigational treatment 211At-MABG introduces a novel approach by using astatine-211 as an active ingredient. This treatment is unique because it delivers targeted radiation directly to tumor cells through a process called radioimmunotherapy. Researchers are excited about 211At-MABG because it has the potential to more precisely target cancer cells, potentially reducing harm to healthy tissue and resulting in fewer side effects compared to traditional radiation therapy. Additionally, the fractionated dosing strategy allows for a controlled delivery of the treatment, which could enhance its effectiveness and tolerability.

What evidence suggests that 211At-MABG might be an effective treatment for neuroendocrine tumors?

Research has shown that 211At-MABG might help treat neuroendocrine tumors by delivering targeted radiation directly to cancer cells. This treatment uses a type of radiation known for effectively killing cancer cells while mostly sparing healthy tissue. Laboratory studies have demonstrated that 211At-MABG can successfully locate and destroy tumor cells in models of neuroblastoma, a cancer often found in the adrenal glands. Although human trial data remains limited, early results in similar conditions appear promising for both effectiveness and safety. This trial will explore different dose levels of 211At-MABG, offering hope for patients with advanced neuroendocrine tumors unresponsive to standard treatments.678910

Who Is on the Research Team?

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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
See 9 more

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.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractionated doses of 211At-MABG administered by IV in weekly doses over one treatment cycle

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants are monitored for long-term safety and effectiveness, including adverse events and response rates

72 months

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+

Citations

Treatment Decision-Making for Neuroendocrine Tumors

The PROMID trial demonstrated clear progression-free survival benefits for octreotide compared with placebo, while the CLARINET trial showed ...

Novel Neuroendocrine Tumor (NET) Therapies

Results showed that octreotide can help slow tumor growth, states Matthew H. Kulke, MD. The phase III RADIANT-4 clinical trial randomized ...

Therapeutic Options for Neuroendocrine Tumors A ...

2,5,17,26-29,32-35 The network meta-analysis found that combination therapies were highly effective, with HRs between 0.31 and 0.35 vs placebo.

Future directions in the treatment of neuroendocrine tumors

Because of the observed long survival after progression of many patients, progression-free survival is recommended as a feasible and relevant primary end point ...

Neuroendocrine Tumor (NET) Treatment Market Report ...

The Global Neuroendocrine Tumor (NET) Treatment Market was valued at USD 2.59 billion in 2025 and is projected to reach USD 4.12 billion by 2032, ...

Efficacy and safety of high-specific-activity >131>I-MIBG ...

The median overall survival was 36.7 mo (95% confidence interval, 29.9–49.1 mo). The most common treatment-emergent adverse events were nausea, ...

Astatine-211 based radionuclide therapy: Current clinical ...

Phase I trials show potential survival benefits for glioblastoma patients treated with 211At-ch81C6, with a median survival of 52 weeks. Ongoing trials aim to ...

Astatine-211 based radionuclide therapy: Current clinical ...

Here, we summarize the main results of the completed clinical trials, further describe ongoing trials, and discuss future prospects.

Safety, Tolerability, and Preliminary Efficacy of [211At] ...

Clinical trial for Neuroblastoma (NB) , Safety, Tolerability, and Preliminary Efficacy of [211At]MABG in Patients With Relapsed or ...

Biodistribution data of ²¹¹At-MABG in mice at 5 min, and at 1 ...

Results: [211At]At-TMP targeted at the DNA, followed by the nucleus, yielded the highest in vitro cytotoxicity per 211At decay. The cytotoxic advantage ...