Clinical Trial · NCT07661641

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

Overview

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

ClinicalTrials.gov

NCT07661641

Drug / Compound

A9-0642

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

A9-0631

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

Eligibility

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.