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RECRUITING
NCT07661641
PHASE1

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.

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

[68Ga]Ga-A9-6217

Administered IV

DIAGNOSTIC_TEST

Low dose [177Lu]Lu-A9-0631

Administered IV

DRUG

[177Lu]Lu-A9-0631

Administered IV

DRUG

[225Ac]Ac-A9-0642

Administered IV

Locations (2)

Melbourne Theranostic Innovation Center

Melbourne N., Victoria, Australia

GenesisCare Murdoch

Murdoch, Western Australia, Australia