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
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha-9 Oncology USA Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
History of uncontrolled allergic reactions and/or known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in either of the therapeutic investigational products.
Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.
Prior external beam radiation therapy to more than 25% of the bone marrow.
Trial design
Treatments tested in this trial
- [68Ga]Ga-A9-6217
- Low dose [177Lu]Lu-A9-0631
- [177Lu]Lu-A9-0631
- [225Ac]Ac-A9-0642
Treatment groups
115 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov