University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Location contact
Abramson Cancer Center
CONTACT
Vivek Narayan, MD, MS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07661420
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1
Philadelphia, Pennsylvania, 19104, United States
Abramson Cancer Center
CONTACT
Vivek Narayan, MD, MS
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)
Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)
Astatine-211 [211At] is a short-lived α emitter conjugated onto meta-astatobenzylguanidine ([211At]MABG)
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).
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).
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'.
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'
Time frame: 8 weeks
Highest dose level at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects
Time frame: 72 months
Type, frequency, severity, and attribution of adverse events. as assessed by CTCAE version 6.0
Time frame: 72 months
Proportion of participants with Partial Response (PR) or Complete Response (CR) per RECIST v1.1 criteria
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
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.
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
Time frame: 12 months
Change from baseline in anti-hypertensive medication dose following a single cycle of fractionated dosing of 211At-MABG
Time frame: 12 months
time from the first administration of fractionated dose of 211At-MABG until the first administration of subsequent anti-cancer therapy
Contact information is provided by the study sponsor or research team.
Abramson Cancer Center
CONTACT
University of Pennsylvania
Other
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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