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NCT Number: NCT07661420

211At-MABG in Adults With Advanced Neuroendocrine Cancers

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location contact

Abramson Cancer Center

CONTACT

Vivek Narayan, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, at least 18 years of age
  • Advanced neuroendocrine cancers requiring systemic therapy and refractory to, ineligible for, declining, or lacking standard treatments.
  • 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.
  • ECOG performance status ≤ 2.
  • Adequate organ function including:
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Measured or estimated GFR ≥ 60 mL/min
  • Serum bilirubin ≤ 1.5x upper limit of normal
  • ALT/AST each ≤ 2.5x upper limit of normal
  • Life expectancy at least 3 months as judged by treating physician

Exclusion criteria

  • Women who are pregnant or breast-feeding will not be eligible for this study.
  • Inability to tolerate study procedures in the opinion of the investigator or treating physician.
  • Serious or unstable medical, psychological, or social conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  • Uncontrolled brain metastasis (Participant must be at least 4 weeks since CNS-directed therapy and no longer requiring corticosteroid therapy).
  • Anticancer therapy, except hormonal therapy or bone supportive therapies, within 14 days of cycle 1 day 1.
  • Has a known additional malignancy (other than the disease under study) that has required active systemic treatment within the past 2 years AND for which the natural history or recent/ongoing treatment could likely interfere with study endpoints or safety of the study treatment per Investigator and Medical Director assessment.

Treatment and study plan

1 MBq/k of 211At-MABG Fractionated

Drug

Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)

2 MBq/k1 of 211At-MABG Fractionated

Drug

Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)

4 MBq/k of 211At-MABG Fractionated

Drug

Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)

Primary outcomes

  1. Evaluate overall study feasibility

    Time frame: 4 weeks

    Proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window (at the overall study level).

  2. Evaluate study feasibility overall study feasibility assessed for operational issues versus treatment-related adverse events.

    Time frame: 4 weeks

    Proportion of fractionated dose administrations either delayed and/or omitted due to operational issues (i.e. insufficient/delayed synthesis) versus treatment-related adverse events (at the overall study level).

Secondary outcomes

  1. Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per patient level

    Time frame: 4 weeks

    The proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window assessed at the 'per patient level'.

  2. Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per 'dose level'.

    Time frame: 4 weeks

    The proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window assessed at the 'per dose level'

  3. The maximum tolerated dose (MTD) and/or Recommended Phase II Dose (RP2D) of 211At-MABG

    Time frame: 8 weeks

    Highest dose level at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects

  4. Incidence of Adverse Events

    Time frame: 72 months

    Type, frequency, severity, and attribution of adverse events. as assessed by CTCAE version 6.0

  5. The objective response rate (ORR) per RECIST 1.1 following a single cycle of fractionated dosing of 211At-MABG

    Time frame: 72 months

    Proportion of participants with Partial Response (PR) or Complete Response (CR) per RECIST v1.1 criteria

  6. The duration of response (DOR) following a single cycle of fractionated dosing of 211At-MABG

    Time frame: 12 months

    Time from treatment initiation until Progressive Disease (as per RECIST v1.1 criteria) among study participants with PR or CR following a single cycle of fractionated dosing of 211At-MABG

  7. The Disease Control Rate (DCR) following a single cycle of fractionated dosing of 211At-MABG

    Time frame: 12 months

    Proportion of participants with PR or CR or Stable Disease (SD) per RECIST v1.1 criteria following a single cycle of fractionated dosing of 211At-MABG.

  8. Biochemical Response (BCR)

    Time frame: 12 months

    Percent change from baseline in serum or urine metanephrines and catecholamines following a single cycle of fractionated dosing of 211At-MABG

  9. Anti-Hypertensive Medication Response

    Time frame: 12 months

    Change from baseline in anti-hypertensive medication dose following a single cycle of fractionated dosing of 211At-MABG

  10. The time to subsequent anti-cancer therapy (time to next treatment) (TTNT)

    Time frame: 12 months

    time from the first administration of fractionated dose of 211At-MABG until the first administration of subsequent anti-cancer therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Abramson Cancer Center

CONTACT

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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