Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors (NCT05636618) | Clinical Trial Compass
RecruitingPhase 1/2
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors
United States300 participantsStarted 2023-09-27
Plain-language summary
This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-Ξ±-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
Who can participate
Age range18 Years β 90 Years
SexALL
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Inclusion criteria
β. Adult (ages β₯18) PRRT-naΓ―ve subjects with NETs or meningioma by local pathology.
β. Disease described clinically as: (a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study (c) Requiring at least 1 prior surgery (resection/biopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.
β. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)
β. Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.
β. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.
β. Demonstration of lesional SSTR expression: (a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. \[68Ga\]DOTATATE, \[64Cu\]DOTATATE, or \[68Ga\]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment
β. ECOG Performance Status β€ 1.
β. Subjects with HIV positivity are allowed if CD4 Count \> 350 cells/ΞΌL.
Exclusion criteria
β
What they're measuring
1
Number of participants with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT-Ξ±-NET
Timeframe: Incidence and severity of DLTs during the first 42 days of study treatment will be assessed.
2
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 in subjects with NETs
Timeframe: Up to week 96
3
ORR per Response Assessment in Neuro-Oncology (RANO) meningioma criteria in subjects with meningioma
Timeframe: Up to week 96
4
Number of subjects with adverse events (AEs)
Timeframe: Until the end of study (3 years after end-of-study visit)
. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of \[212Pb\]VMT-Ξ±-NET.
β. Known additional malignancy that is progressing or requires active treatment.
β. Pregnancy or breastfeeding a child.
β. Febrile illness within 48 hours of any scheduled \[212Pb\]VMT-Ξ±-NET administration should be rescheduled \> 48 hours after resolution of fever\].
β. Treatment with another investigational medicinal product within 30 days of anticipated treatment.
β. Prior treatment with systemic PRRT based therapies (i.e., \[90Y\] DOTATATE/DOTATOC or \[177Lu\] DOTATATE)
β. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.
β. External beam radiation therapy (EBRT) must be completed at least 30 days prior to enrollment.