Targeted radiopharmaceuticals for GRPR-positive cancers in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label phase 1-1b trial evaluates the safety, dosimetry, and initial efficacy of Lu-177-A9-0631 and Ac-225-A9-0642 in adults with GRPR-expressing locally advanced, unresectable, or metastatic solid tumors. Phase 1 uses dose escalation to determine the maximum tolerated dose and the recommended phase 2 dose, while Phase 1b expands at RP2D to further assess safety, tumor targeting, and preliminary efficacy across specified tumor types. Interventions include a diagnostic Ga-68 imaging agent and therapeutic radiopharmaceuticals with low-dose Lu-177 and Lu-177 as well as Ac-225 labeled compounds. Eligibility requires adult patients with measurable disease, adequate organ function, GRPR expression confirmed by imaging, and prior progression or intolerance to standard therapies. The study is led by Alpha-9 Oncology USA with sites in Australia.

Why it matters

Who can join: the full rules

Inclusion 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.
* Progression from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types: prostate cancer; HR+/HER2- breast cancer; colorectal cancer; and GRPR-positive solid tumors.
* Have GRPR-expressing disease as confirmed by PET / CT or SPECT imaging.
* Adequate organ function within 14 days of first administration of investigational therapeutic product.
* At least 4 weeks from prior major surgery.

Exclusion Criteria:

* 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.
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Any active infection.

Where it's running

• Melbourne Theranostic Innovation Center
  Melbourne N., Victoria, Australia Recruiting
• GenesisCare Murdoch
  Murdoch, Western Australia, Australia Not yet recruiting

Study contacts

• Study coordinator: Stephen Hull, MD
• Email: shull@a9oncology.com
• Phone: +1-778-715-3303

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.