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A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors
Sponsor: Alpha-9 Oncology USA Inc.
Summary
This is a Phase 1-1b multicenter clinical study to evaluate the safety, efficacy, and dosimetry of \[177Lu\]Lu-A9-0631 and \[225Ac\]Ac-0642 in participants with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.
Official title: A Phase 1-1b Study to Evaluate the Safety, Efficacy, and Dosimetry of [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642, and [68Ga]Ga-A9-6217 in Participants With GRPR+ Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
115
Start Date
2026-07-01
Completion Date
2029-12
Last Updated
2026-06-22
Healthy Volunteers
No
Interventions
[68Ga]Ga-A9-6217
Administered IV
Low dose [177Lu]Lu-A9-0631
Administered IV
[177Lu]Lu-A9-0631
Administered IV
[225Ac]Ac-A9-0642
Administered IV
Locations (2)
Melbourne Theranostic Innovation Center
Melbourne N., Victoria, Australia
GenesisCare Murdoch
Murdoch, Western Australia, Australia