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RecruitingLast updated: 2 September 2026

A9-0600-01: Testing two new targeted radioactive treatments for people with advanced GRPR-positive solid cancers.A Phase 1-1b Study to Evaluate the Safety, Efficacy, and Dosimetry of [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642, and [68Ga]Ga-A9-6217 in Participants With GRPR+ Tumors

Trial purpose

Medical clipboardCancer treatment; Diagnostic

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

A9-0600-01

Clinical summary

Summary

This trial is testing two new targeted radioactive treatments, [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642, in people with advanced cancers that have a protein called Gastrin-Releasing Peptide Receptor (GRPR) on their cancer cells.
 
The treatments are designed to attach to GRPR-positive cancer cells and deliver radiation directly to the tumour. Researchers want to find out how safe these treatments are, what side effects they may cause, how the treatments move through the body, and whether they can help control cancer growth.

Who can take part?
You may be eligible for this study if:

  • you have a solid cancer that:
    • has spread to other parts of the body (metastatic), or
    • has grown locally and cannot be removed with surgery (locally advanced or unresectable)
  • your cancer has a protein called Gastrin-Releasing Peptide Receptor (GRPR)
  • your cancer has progressed despite treatment, you were unable to tolerate treatment, or you are not eligible for standard treatment options

The study has two parts.

Phase 1
Researchers will test different dose levels of the study treatments to find the safest dose, better understand side effects, measure how the treatment is taken up by tumours and normal organs, and identify the recommended dose for future studies.

Phase 1b
Once the recommended dose has been identified, more participants will receive the treatment. This part of the study will focus on people with HR+/HER2-negative breast cancer, prostate cancer and colorectal cancer, while also including people with other GRPR-positive solid tumours.

Conditions

This trial is treating people with advanced solid cancers that are GRPR+

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Alpha-9 Oncology USA Inc.

Scientific Title

A Phase 1-1b Study to Evaluate the Safety, Efficacy, and Dosimetry of [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642, and [68Ga]Ga-A9-6217 in Participants With GRPR+ Tumors

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