PheochromocytomaPhase 1NCT07661420
211At-MABG in Adults With Advanced Neuroendocrine Cancers
A Phase 1 study testing 1 MBq/k of 211At-MABG Fractionated, 2 MBq/k1 of 211At-MABG Fractionated and 4 MBq/k of 211At-MABG Fractionated in people with Pheochromocytoma and Paraganglioma, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma, Paraganglioma, Neuroendocrine Tumors
- What is being tested?
- 1 MBq/k of 211At-MABG Fractionated, 2 MBq/k1 of 211At-MABG Fractionated and 4 MBq/k of 211At-MABG Fractionated
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Aug 2032
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abramson Cancer Center contact
United States1 site
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Abramson Cancer Center
Vivek Narayan, MD, MS
About this study
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).
- Conditions
- Pheochromocytoma, Paraganglioma, Neuroendocrine Tumors, Medullary Thyroid Cancer, Bronchial Carcinoid, Gastroenteropancreatic Neuroendocrine Neoplasm
- Being tested
- 1 MBq/k of 211At-MABG Fractionated, 2 MBq/k1 of 211At-MABG Fractionated, 4 MBq/k of 211At-MABG Fractionated
- Medical subject headings
- Pheochromocytoma, Paraganglioma, Neuroendocrine Tumors, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 MBq/k of 211At-MABG FractionatedDrug
Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)
2 MBq/k1 of 211At-MABG FractionatedDrug
Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)
4 MBq/k of 211At-MABG FractionatedDrug
Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)
| Study group | Role | What they receive |
|---|---|---|
| Dose Level -1: Fractionated 211At-MABG | Experimental | One treatment cycle (1 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (0.25 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses). Receives: Drug: 1 MBq/k of 211At-MABG Fractionated |
| Dose Level 1: Fractionated 211At-MABG | Experimental | One treatment cycle (2 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (0.5 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses). Receives: Drug: 2 MBq/k1 of 211At-MABG Fractionated |
| Dose Level 2: Fractionated 211At-MABG | Experimental | One treatment cycle (4 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (1 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses). Receives: Drug: 4 MBq/k of 211At-MABG Fractionated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate overall study feasibility
Proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window (at the overall study level).
Measured: 4 weeks
Evaluate study feasibility overall study feasibility assessed for operational issues versus treatment-related adverse events.
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).
Measured: 4 weeks
Secondary outcomes (10)
Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per patient level
The proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window assessed at the 'per patient level'.
Measured: 4 weeks
Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per 'dose level'.
The proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window assessed at the 'per dose level'
Measured: 4 weeks
The maximum tolerated dose (MTD) and/or Recommended Phase II Dose (RP2D) of 211At-MABG
Highest dose level at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects
Measured: 8 weeks
Incidence of Adverse Events
Type, frequency, severity, and attribution of adverse events. as assessed by CTCAE version 6.0
Measured: 72 months
The objective response rate (ORR) per RECIST 1.1 following a single cycle of fractionated dosing of 211At-MABG
Proportion of participants with Partial Response (PR) or Complete Response (CR) per RECIST v1.1 criteria
Measured: 72 months
The duration of response (DOR) following a single cycle of fractionated dosing of 211At-MABG
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
Measured: 12 months
The Disease Control Rate (DCR) following a single cycle of fractionated dosing of 211At-MABG
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.
Measured: 12 months
Biochemical Response (BCR)
Percent change from baseline in serum or urine metanephrines and catecholamines following a single cycle of fractionated dosing of 211At-MABG
Measured: 12 months
Anti-Hypertensive Medication Response
Change from baseline in anti-hypertensive medication dose following a single cycle of fractionated dosing of 211At-MABG
Measured: 12 months
The time to subsequent anti-cancer therapy (time to next treatment) (TTNT)
time from the first administration of fractionated dose of 211At-MABG until the first administration of subsequent anti-cancer therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vivek Narayan, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661420
- Sponsor's protocol ID
- 26-6403
- Other IDs
- 1R01CA300202
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No