Breast CancerPhase 1NCT07661641
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
A Phase 1 study testing [68Ga]Ga-A9-6217, Low dose [177Lu]Lu-A9-0631 and [177Lu]Lu-A9-0631 in people with Breast Cancer and Prostate Cancer, run by Alpha-9 Oncology USA Inc. at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- [68Ga]Ga-A9-6217, Low dose [177Lu]Lu-A9-0631 and [177Lu]Lu-A9-0631
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Jul 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Melbourne Theranostic Innovation Center
Melbourne N., Victoria, 3051
Prof. Rod Hicks, +61 03 9454 5800, rod.hicks@premit.net.au
Prof. Rod Hicks
- Not yet recruiting
GenesisCare Murdoch
Murdoch, Western Australia, 6150
Prof. Joe Cardaci, +610893661500, joe.cardaci@genesiscare.com
Prof. Joe Cardaci
About this study
Official 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
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.
Read the detailed description
This is a multicenter, open-label Phase 1-1b study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 in subjects with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.
The study consists of two parts (Phase 1 and 1b).
Phase 1 is the dose escalation portion of the study. The aim of the Phase 1 is to evaluate the safety and tolerability as well as the normal organ and tumor dosimetry of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642, and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Phase 1b will be the dose expansion portion of the study. The aim of the Phase 1b will be to further evaluate the safety, efficacy, and normal organ and tumor dosimetry of [177 Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 administered at the RP2D in subjects with (1) Locally advanced, unresectable, or metastatic HR+/HER2- breast cancer; (2) Locally advanced, unresectable, or metastatic prostate cancer; (3) Locally advanced, unresectable, or metastatic CRC; and (4) Other locally advanced, unresectable, or metastatic GRPR-positive solid tumors.
- Being tested
- [68Ga]Ga-A9-6217, Low dose [177Lu]Lu-A9-0631, [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642
- Keywords
- breast cancer, prostate cancer, colorectal cancer (CRC), GRPR-positive solid tumors, radiopharmaceuticals, theranostics
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-A9-6217Diagnostic test
Administered IV
Low dose [177Lu]Lu-A9-0631Diagnostic test
Administered IV
[177Lu]Lu-A9-0631Drug
Administered IV
[225Ac]Ac-A9-0642Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Not described Receives: Diagnostic Test: [68Ga]Ga-A9-6217; Diagnostic Test: Low dose [177Lu]Lu-A9-0631; Drug: [177Lu]Lu-A9-0631; Drug: [225Ac]Ac-A9-0642 |
| Phase 1B Dose Expansion | Experimental | Not described Receives: Diagnostic Test: [68Ga]Ga-A9-6217; Diagnostic Test: Low dose [177Lu]Lu-A9-0631; Drug: [177Lu]Lu-A9-0631; Drug: [225Ac]Ac-A9-0642 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.
Measured: From the first dose of study drug up to the End of Treatment (30 days after the last dose)
Phase 1: Number of Patients with Dose-Limiting Toxicities (DLTs).
DLTs is defined as any predefined AE occurring during the DLT observation period.
Measured: Up to 28 days following first study treatment
Phase 1: Maximum tolerated dose (MTD)
Incidence of dose-limiting toxicity (DLT) per dose level of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642.
Measured: Up to 28 days following first study treatment
Secondary outcomes (2)
Phase 1-1b: Absorbed dose estimates (Gy) in normal organs for [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
Measured: Up to 7 days after each injection for up to 6 cycles (each cycle is 28 days)
Phase 1-1b: Objective Response Rate (ORR)
Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST 1.1, by dose level.
Measured: Every 8 ± 1 weeks until radiographic disease progression or up to 12 months after the last dose of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha-9 Oncology USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Hull, MD, Study director, Alpha 9 Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661641
- Sponsor's protocol ID
- A9-0600-01
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07661641
- Acronym / sponsor ID
- A9-0600-01
- Keywords
- breast cancer, prostate cancer, colorectal cancer (CRC), GRPR-positive solid tumors, radiopharmaceuticals, theranostics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Alpha-9 Oncology USA Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, open-label Phase 1-1b study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 in subjects with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.
The study consists of two parts (Phase 1 and 1b).
Phase 1 is the dose escalation portion of the study. The aim of the Phase 1 is to evaluate the safety and tolerability as well as the normal organ and tumor dosimetry of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642, and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Phase 1b will be the dose expansion portion of the study. The aim of the Phase 1b will be to further evaluate the safety, efficacy, and normal organ and tumor dosimetry of [177 Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 administered at the RP2D in subjects with (1) Locally advanced, unresectable, or metastatic HR+/HER2- breast cancer; (2) Locally advanced, unresectable, or metastatic prostate cancer; (3) Locally advanced, unresectable, or metastatic CRC; and (4) Other locally advanced, unresectable, or metastatic GRPR-positive solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Diagnostic Test: [68Ga]Ga-A9-6217, Diagnostic Test: Low dose [177Lu]Lu-A9-0631, Drug: [177Lu]Lu-A9-0631, Drug: [225Ac]Ac-A9-0642 |
| Phase 1B Dose Expansion | Experimental | Diagnostic Test: [68Ga]Ga-A9-6217, Diagnostic Test: Low dose [177Lu]Lu-A9-0631, Drug: [177Lu]Lu-A9-0631, Drug: [225Ac]Ac-A9-0642 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-A9-6217Administered IV | Diagnostic test | Phase 1 Dose Escalation, Phase 1B Dose Expansion |
| Low dose [177Lu]Lu-A9-0631Administered IV | Diagnostic test | Phase 1 Dose Escalation, Phase 1B Dose Expansion |
| [177Lu]Lu-A9-0631Administered IV | Drug | Phase 1 Dose Escalation, Phase 1B Dose Expansion |
| [225Ac]Ac-A9-0642Administered IV | Drug | Phase 1 Dose Escalation, Phase 1B Dose Expansion |
Primary outcome
Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity
Time frame: From the first dose of study drug up to the End of Treatment (30 days after the last dose)
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.
Phase 1: Number of Patients with Dose-Limiting Toxicities (DLTs).
Time frame: Up to 28 days following first study treatment
DLTs is defined as any predefined AE occurring during the DLT observation period.
Phase 1: Maximum tolerated dose (MTD)
Time frame: Up to 28 days following first study treatment
Incidence of dose-limiting toxicity (DLT) per dose level of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642.
2 secondary outcomes
Phase 1-1b: Absorbed dose estimates (Gy) in normal organs for [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
Time frame: Up to 7 days after each injection for up to 6 cycles (each cycle is 28 days)
Phase 1-1b: Objective Response Rate (ORR)
Time frame: Every 8 ± 1 weeks until radiographic disease progression or up to 12 months after the last dose of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Hull, MD study director
Alpha 9 Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [68Ga]Ga-A9-6217, Low dose [177Lu]Lu-A9-0631 and [177Lu]Lu-A9-0631 in people with Breast Cancer and Prostate Cancer, run by Alpha-9 Oncology USA Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Hull, MD (+1-778-715-3303, shull@a9oncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity (time frame: From the first dose of study drug up to the End of Treatment (30 days after the last dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.