XCancer

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

Description:

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.

Sponsor:

Unknown Organization

Phase:

Phase 1

Contacts:

Stephen Hull, MD (STUDY_DIRECTOR)

Stephen Hull, MD (CONTACT)

shull@a9oncology.com

+1-778-715-3303

Government Study Link:

NCT07661641 - Click here to see study on

ClinicalTrials.gov

A9-0642

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides

A9-0631

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Inclusion
  • Adequate organ function within 14 days of first administration of investigational therapeutic product.
  • Have measurable target lesion per RECIST v1.1.
  • At least 4 weeks from prior major surgery.
  • Have GRPR-expressing disease as confirmed by PET / CT or SPECT imaging.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion
  • Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.
  • Received anticancer treatment including but not limited to chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) or 5 half-lives, (t1/2) whichever is shorter, to the administration of therapeutic investigational product.
  • Prior external beam radiation therapy to more than 25% of the bone marrow.