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Not yet recruiting NCT07661420

211At-MABG in Adults With Advanced Neuroendocrine Cancers

Phase I Interventional Pheochromocytoma Paraganglioma Neuroendocrine Tumors Medullary Thyroid Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 1 MBq/k of 211At-MABG Fractionated, 2 MBq/k1 of 211At-MABG Fractionated, 4 MBq/k of 211At-MABG Fractionated.
Who it may be relevant to
Registry conditions: Pheochromocytoma, Paraganglioma, Neuroendocrine Tumors, Medullary Thyroid Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • Drug 1 MBq/k of 211At-MABG Fractionated
    Astatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
  • Drug 2 MBq/k1 of 211At-MABG Fractionated
    Astatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)
  • Drug 4 MBq/k of 211At-MABG Fractionated
    Astatine-211 \[211At\] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine (\[211At\]MABG)

Primary outcome measures

  • Evaluate overall study feasibility [Time frame: 4 weeks]
  • Evaluate study feasibility overall study feasibility assessed for operational issues versus treatment-related adverse events. [Time frame: 4 weeks]
Secondary outcome measures (10)
  • Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per patient level [Time frame: 4 weeks]
  • 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 maximum tolerated dose (MTD) and/or Recommended Phase II Dose (RP2D) of 211At-MABG [Time frame: 8 weeks]
  • Incidence of Adverse Events [Time frame: 72 months]
  • The objective response rate (ORR) per RECIST 1.1 following a single cycle of fractionated dosing of 211At-MABG [Time frame: 72 months]
  • The duration of response (DOR) following a single cycle of fractionated dosing of 211At-MABG [Time frame: 12 months]
  • The Disease Control Rate (DCR) following a single cycle of fractionated dosing of 211At-MABG [Time frame: 12 months]
  • Biochemical Response (BCR) [Time frame: 12 months]
  • Anti-Hypertensive Medication Response [Time frame: 12 months]
  • The time to subsequent anti-cancer therapy (time to next treatment) (TTNT) [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Pennsylvania - Abramson Cancer Center — Philadelphia

Identifiers

NCT: NCT07661420 · 26-6403 · 1R01CA300202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗