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

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.

Trial Details

NCT ID
NCT07661641
Phase
PHASE1
Sponsor
Alpha-9 Oncology USA Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • [68Ga]Ga-A9-6217
  • Low dose [177Lu]Lu-A9-0631
  • [177Lu]Lu-A9-0631
  • [225Ac]Ac-A9-0642
Locations (sample)
  • Melbourne N., Victoria, Australia
  • Murdoch, Western Australia, Australia|-32.06987,115.83757

Key Eligibility Criteria

  • Participant has provided written informed consent prior to any study-specific procedure.
  • Age ≥ 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Have measurable target lesion per RECIST v1.1.

For full eligibility, visit ClinicalTrials.gov.

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