Metastatic Breast CancerEarly Phase 1DOTA-STR-17126NCT07608848
First-in-human Diagnostic Imaging Profile of the Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu] Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer
A Early Phase 1 study testing [177Lu]Lu-DOTA-STR-17126 and [68Ga]Ga-DOTA-STR-17126 in people with Metastatic Breast Cancer and Metastatic Prostate Cancer, run by Integrated Haematology and Oncology Network at 1 site in Australia.
Trial summary
This is an open-label, first-in-human, exploratory Phase 0 study evaluating the safety and diagnostic imaging performance of the DOTA-STR-17126 theranostic pair in patients with advanced or metastatic breast or prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Prostate Cancer, GRPR-Targeted Molecular Imaging
- What is being tested?
- [177Lu]Lu-DOTA-STR-17126 and [68Ga]Ga-DOTA-STR-17126
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 28 May 2026to 31 May 2029
- Phase
- Early 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
- Inclusion criteria refer to the enrolment of participants for the PET/CT and SPECT/CT imaging with the radioligands; PET imaging tracer [68Ga]Ga-DOTA-STR-17126 and with the SPECT imaging tracer [177Lu]Lu-DOTA-STR-17126. Participants must meet all of the following inclusion criteria to be eligible for enrolment.
- Ability to understand and willingness to provide informed consent
- Adults ≥ 18 years of age
- Must have the following histologically or cytologically confirmed diagnosis of advanced or metastatic i. breast cancer ii. prostate cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Participant must have clinical or radiological documented tumour progression as established by the Investigator within 30 days of signing consent for the study
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- Participants who have exhausted standard-of-care systemic therapies in their metastatic setting. At least one detectable by conventional imaging tumour lesion with any diameter of ≥ 1 cm in size
- Participants must have adequate organ and bone marrow function, defined as follows:
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 ii. Platelet count ≥ 100,000/mm3 iii. Haemoglobin ≥ 9.0 g/dL iv. AST, ALT, alkaline phosphatase ≤ 3 times upper limit of normal (ULN) if there is no evidence of liver metastases or ≤5 ULN in the presence of liver metastases v. Total bilirubin ≤ 2 times upper limit of normal (ULN) vi. Creatinine ≤ 2 times ULN and creatinine clearance (CrCL) ≥ 60mL/min using the Cockcroft Gault equation (Appendix 2)
- Able to remain still for up to 60 minutes per scan
- Any other condition which, in the opinion of the Investigator, would preclude participation in this study Optional: Participants that have available archival tissue (at least 15 consecutive, unstained, formalin-fixed, paraffin embedded (FFPE) slides or 1 FFPE block), or a fresh tumour biopsy sample that opt to provide samples will be used for GRPR analysis (histology staining or RNA measurements). Participants without any archival tissue or fresh biopsy sample, or who refuse to provide archival tissue are still eligible for the study.
Who cannot join
- Participants must not be enrolled into the trial if one or more of the following criteria are met. Participants must NOT meet any of the following Exclusion criteria to be eligible for enrolment:
- Known hypersensitivity to the investigational medicinal products (DOTA-STR-17126) or any of the excipients.
- Participants with Class 3 or 4 New York Heart Association (NYHA) Congestive Heart Failure.
- Average QTc (using the Fridericia correction calculation) > 470 msec for females and QTcF >450 msec for males on screening ECG or history of congenital long QT syndrome.
- Clinically significant bleeding within two weeks prior to trial entry (i.e., gastrointestinal bleeding, intracranial bleeding).
- Pregnant or lactating women. i. For female participants of childbearing potential or male participants with female partner of childbearing potential, who are not willing to practice highly effective contraception during the trial and for at least 6 months after [177Lu] Lu-DOTA-STR-17126 administration ii. Sexually active males must use a condom during intercourse while taking the drug and for 4 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of childbearing potential should use highly effective contraceptive methods during and up to 6 months after stopping treatment.
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- Have any medical condition that impairs complete bladder emptying. Participants with permanent urinary indwelling catheter (IDC) or nephrostomy may be allowed to enrol on a case-by-case basis in discussion with Principal Investigator, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
- Major surgery, defined as any surgical procedure that involves general anaesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 30 days before study day 1 or anticipated surgery within the subsequent 43 days (6 weeks).
- Has an additional active malignancy requiring therapy within the past 2 years.
- History of another malignancy within 3 years before study enrolment. A subject with the following malignancies is allowed if considered cured or unlikely to recur within 3 years:
- Carcinoma of the skin without melanomatous features ii. Curatively treated cervical carcinoma in situ iii. Bladder tumours considered superficial such as non-invasive (T1a) and carcinoma in situ (T1s), thyroid papillary cancer with prior treatment
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy within 30 days prior to trial enrolment.
- Psychiatric illness/social situations that would interfere with compliance with study requirements.
- Cannot undergo PET/CT scanning because of weight limits (350 lbs or 160 kg).
- Prior exposure to any other GRPR-targeting therapeutic agents.
- Prior treatment with any systemic anti-cancer therapy including chemotherapy, immunotherapy, biological therapy, radiation therapy, biologic, hormonal or herbal therapy, or any investigational therapy or investigational device, unless:
- Standard of care or maintenance therapy such as, luteinizing hormone-releasing hormone (LHRH) or gonadotropin releasing hormone (GnRH) for patients with prostate cancer; selective estrogen receptor modulators or aromatase inhibitors or GnRH inhibitors for breast cancer, ii. Within more than 30 days of chemotherapy, herbal therapies and monoclonal antibodies, iii. Within more than 5 half-lives for biologic/non-cytotoxic targeted agents, iv. Within more than 8 weeks prior radiation therapies External Beam Radiotherapy (EBRT) and/or Radioligand Therapy (RLT). Focal palliative radiotherapy given within 8 weeks prior to the low dose of [177Lu] Lu-DOTA-STR-17126 may be approved on a case-by-case basis, if it is determined not to put the participant at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome, v. For participants who received radiotherapy (EBRT and/or RLT) more than 8 weeks prior to the low dose of 177Lu-DOTA-STR-17126, efforts should be made to calculate the prior radiation absorbed dose to each critical organ such as the kidneys, liver, lungs, and bone marrow.
- Patients with a history of inflammatory disease which according to the investigator may interfere with correct evaluation of radioactive uptake, especially those affecting the thoraco-abdominal cavities (i.e., autoimmune, granulomatous disease).
- Any clinically significant toxicity (with the exception of alopecia) related to prior anti-tumour therapy not resolved to Grade 1 or baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Duncan Colyer, RN BN PGDip contact
Australia1 site, 1 recruiting
- Recruiting
Icon Cancer Centre Hollywood
Perth, Western Australia, 6009
ICC Hollywood Admin Team, +61 8 6326 1130, admin.hollywood@icon.team
Dr Nat P Lenzo, MD
About this study
Official title: An Open-label, First-in-human, Exploratory Imaging Study of the DOTA-STR-17126 Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low-dose [177Lu]Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer
This is an open-label, first-in-human, exploratory Phase 0 study evaluating the safety and diagnostic imaging performance of the DOTA-STR-17126 theranostic pair in patients with advanced or metastatic breast or prostate cancer. The study investigates [68Ga]Ga-DOTA-STR-17126 for PET imaging and, in patients with positive GRPR uptake, a low dose of [177Lu]Lu-DOTA-STR-17126 for SPECT imaging and dosimetry.
The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of imaging quality, biodistribution, pharmacokinetics, and radiation dosimetry. Exploratory objectives assess correlations between GRPR expression in tumour tissue and imaging uptake.
The study is conducted at a single centre in Australia, with 12 evaluable participants (up to 20 enrolled), and supports the development of a GRPR-targeted theranostic approach for personalised cancer management.
Read the detailed description
This study is an open-label, first-in-human, exploratory Phase 0 clinical trial conducted at a single centre in Australia to characterise the safety profile, imaging performance, biodistribution, pharmacokinetics, and radiation dosimetry of the DOTA-STR-17126 theranostic pair in patients with advanced malignancy. The investigational approach uses a stepwise theranostic design in which all enrolled participants receive a single intravenous bolus administration of the GRPR-targeted PET radiopharmaceutical [68Ga]Ga-DOTA-STR-17126, followed by serial whole-body PET/CT imaging to evaluate tumour uptake and normal organ distribution. Participants demonstrating sufficient GRPR-positive tumour uptake on PET imaging may subsequently receive a single low-dose, slow intravenous infusion of [177Lu]Lu-DOTA-STR-17126, with serial planar and SPECT/CT imaging performed over several days to assess biodistribution and enable organ and tumour dosimetry calculations. Blood and urine samples are collected at predefined time points to support pharmacokinetic and radiation dosimetry analyses, alongside intensive clinical and laboratory safety monitoring. The study is exploratory in nature and is designed to optimise imaging protocols, generate human dosimetry data, and establish an initial safety and tolerability profile for this novel GRPR antagonist-based theranostic platform, thereby informing the design and dose selection for subsequent phase I/II clinical development.
- Conditions
- Metastatic Breast Cancer, Metastatic Prostate Cancer, GRPR-Targeted Molecular Imaging, Theranostic Radiopharmaceuticals, Cancer, Active Cancer
- Being tested
- [177Lu]Lu-DOTA-STR-17126, [68Ga]Ga-DOTA-STR-17126
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-DOTA-STR-17126Drug
Participants will receive a low dose of [177Lu]Lu-DOTA-STR-17126, dose activity: 1.0+/-0.5 GBq (50 micrograms peptide) of [177Lu]Lu-DOTA-STR-17126 precursor will be administered as a slow infusion.
[68Ga]Ga-DOTA-STR-17126Drug
Participants will receive a single intravenous bolus dose of 150+/-50MBq (25 - 50 micrograms) of [68Ga]Ga-DOTA-STR-17126 precursor.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu]Lu-DOTA-STR-17126 | Experimental | The intervention involves administration of two radiopharmaceuticals under investigation:
Part 1: [68Ga] Ga-DOTA-STR-17126 is used as a PET imaging tracer to identify tumour lesions with high expression of GRPR. Participants will receive a single intravenous bolus dose of 150+/-50MBq (50 micrograms) of DOTA-STR-17126 precursor.
Part 2: Participants who have GRPR positive lesions identified by [68Ga] Ga-DOTA-STR-17126 PET imaging will receive a low Dose [177Lu] Lu-DOTA-STR-17126. Eligible participant(s) will receive 1.0+/-0.5GBq (50 microgram peptide) dose of [177Lu] Lu-DOTA-STR-17126, administered as a slow intravenous infusion. SPECT/CT scans will be performed to assess the biodistribution, dosimetry, and extrapolation of potential therapeutic dose potential of the radiopharmaceutical. Receives: Drug: [177Lu]Lu-DOTA-STR-17126; Drug: [68Ga]Ga-DOTA-STR-17126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory parameters (hematology, blood chemistry, and urinalysis), abnormal Physical examinations findings
- To evaluate adverse events (AEs) and serious adverse events (SAEs) by means of Common Toxicity Criteria Adverse Events (CTCAE version 5.0 Nov 2017); Assess occurrence and severity of AEs and SAEs; Monitor safety laboratory parameters (haematology, blood chemistry, and urinalysis) before, during and after IMP injections.
The Common Terminology Criteria for Adverse Events (CTCAE) is a standardized, 1-5 severity grading system for classifying cancer treatment side effects (adverse events). Grades range from mild (1) to death (5). It is widely used in oncology to determine treatment safety, drug dosage modifications, and to document clinical trial toxicity
Measured: Day 43
Secondary outcomes (6)
Standardized Uptake Value (SUV) of [⁶⁸Ga]Ga-DOTA-STR-17126
Calculation of Standardized Uptake Value (SUV) (max, mean, peak) * between tumour and suitable reference organs (using liver parenchyma, lung parenchyma and mediastinal blood pool as reference regions) by PET/CT imaging, Higher numbers e.g., above 2.5 often highly suggestive of malignancy (cancerous growth. Lower numbers e.g., below 2.5 frequently indicate benign (non-cancerous) growths. SUVmax vs. SUVmean: A scan report will usually specify SUV_max as the highest, most active single point in the tumor or SUV_mean (the average activity across the entire tumor.
Measured: Day 2 post-dose
PET/CT image quality of [⁶⁸Ga]Ga-DOTA-STR-17126
Qualitative assessment of PET/CT image quality using a 5-point scale from excellent to poor image, with parameters such as intensity, sharpness, noise of tumour uptake related to reference regions.
Measured: Day 2 post-dose
Tumour to Background Ratio (TBR) of [⁶⁸Ga]Ga-DOTA-STR-17126
The ability to confirm preferential accumulation of [68Ga] Ga-DOTA-STR-17126 in target lesions and comparable detectability of tumour lesions by PET/CT, taking also into account the extent of uptake in non-target normal organs, and establish intra-participant image quality protocol.
- Tumour to Background Ratio (TBR). High TBR: Indicates a "hot" or very active tumor that is easy to distinguish from the surrounding healthy tissue (e.g., a TBR of 3.0 or higher). Low TBR: Indicates that the tumor looks very similar to the surrounding background tissue, which can make it difficult to identify or measure accurately.
Measured: Day 2 post-dose
Concentration of [68Ga]Ga-DOTA-STR-17126 and [177Lu]Lu-DOTA-STR-17126
Calculate concentration of [68Ga]Ga-DOTA-STR-17126 and of [177Lu]Lu-DOTA-STR-17126 in blood by counting radioactivity in respective samples at specific time intervals (radio-PK)
Measured: Day 1 post-dose, Day 2, Day 4, Day 8
Percentage of injected activity (%IA) in tumour and non-tumour organs
Calculate retention pattern within body and blood pool by the percentage of injected activity (%IA) in tumour and non-tumour organs
Measured: Day 1 post-dose, Day 2, Day 4, Day 8
Calculation of absorbed dose (AD, mGy/MBq)
Calculation of absorbed dose (AD, mGy/MBq) and effective whole-body dose (ED, mSv/MBq) of [68Ga]Ga-DOTA-STR-17126 and [177Lu]Lu-DOTA-STR-17126
The dosimetry analysis will enable estimated radiation absorbed doses from the radioligand therapeutic drug candidate [177Lu]Lu-DOTA-STR-17126 in organs and tumour lesions per unit administered activity (Gy/GBq).
Measured: Day 1 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start28 May 2026
- Primary completion30 May 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants are enrolled into one treatment/imaging group, with no control or comparison arm. Every participant follows the same study pathway (initial PET imaging with \[68Ga\]Ga-DOTA-STR-17126, with optional progression to low-dose \[177Lu\]Lu-DOTA-STR-17126 based on imaging findings), consistent with an open-label, non-randomised, single-arm, exploratory Phase 0 design.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrated Haematology and Oncology Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nat Lenzo, MD, Principal investigator, Integrated Hematology Oncology Network (Icon Group)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608848
- Sponsor's protocol ID
- 2025-11-1840
- Other IDs
- ACTRN12626000679381
- Acronym
- DOTA-STR-17126
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Future use of research data Data collected during the study may be utilised in future research by the Principal Investigators, Sponsor and collaborating researchers to advance knowledge about cancer and its treatments. Proposals for access to trial data must be reviewed and approved by the PI. Participants in this study will be asked to grant advanced permission for the possible future sharing of the data collected in this study. Additional participant consent for use of the data will only be sought if it is a requirement of the HREC.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, First-in-human, Exploratory Imaging Study of the DOTA-STR-17126 Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low-dose [177Lu]Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT07608848
- Acronym / sponsor ID
- DOTA-STR-17126 / 2025-11-1840
- Conditions
- Metastatic Breast Cancer, Metastatic Prostate Cancer, GRPR-Targeted Molecular Imaging, Theranostic Radiopharmaceuticals, Cancer, Active Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Integrated Haematology and Oncology NetworkUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 27 May 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 an open-label, first-in-human, exploratory Phase 0 study evaluating the safety and diagnostic imaging performance of the DOTA-STR-17126 theranostic pair in patients with advanced or metastatic breast or prostate cancer. The study investigates [68Ga]Ga-DOTA-STR-17126 for PET imaging and, in patients with positive GRPR uptake, a low dose of [177Lu]Lu-DOTA-STR-17126 for SPECT imaging and dosimetry.
The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of imaging quality, biodistribution, pharmacokinetics, and radiation dosimetry. Exploratory objectives assess correlations between GRPR expression in tumour tissue and imaging uptake.
The study is conducted at a single centre in Australia, with 12 evaluable participants (up to 20 enrolled), and supports the development of a GRPR-targeted theranostic approach for personalised cancer management.
Detailed description
This study is an open-label, first-in-human, exploratory Phase 0 clinical trial conducted at a single centre in Australia to characterise the safety profile, imaging performance, biodistribution, pharmacokinetics, and radiation dosimetry of the DOTA-STR-17126 theranostic pair in patients with advanced malignancy. The investigational approach uses a stepwise theranostic design in which all enrolled participants receive a single intravenous bolus administration of the GRPR-targeted PET radiopharmaceutical [68Ga]Ga-DOTA-STR-17126, followed by serial whole-body PET/CT imaging to evaluate tumour uptake and normal organ distribution. Participants demonstrating sufficient GRPR-positive tumour uptake on PET imaging may subsequently receive a single low-dose, slow intravenous infusion of [177Lu]Lu-DOTA-STR-17126, with serial planar and SPECT/CT imaging performed over several days to assess biodistribution and enable organ and tumour dosimetry calculations. Blood and urine samples are collected at predefined time points to support pharmacokinetic and radiation dosimetry analyses, alongside intensive clinical and laboratory safety monitoring. The study is exploratory in nature and is designed to optimise imaging protocols, generate human dosimetry data, and establish an initial safety and tolerability profile for this novel GRPR antagonist-based theranostic platform, thereby informing the design and dose selection for subsequent phase I/II clinical development.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are enrolled into one treatment/imaging group, with no control or comparison arm. Every participant follows the same study pathway (initial PET imaging with [68Ga]Ga-DOTA-STR-17126, with optional progression to low-dose [177Lu]Lu-DOTA-STR-17126 based on imaging findings), consistent with an open-label, non-randomised, single-arm, exploratory Phase 0 design.
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu]Lu-DOTA-STR-17126 | Experimental | Drug: [177Lu]Lu-DOTA-STR-17126, Drug: [68Ga]Ga-DOTA-STR-17126The intervention involves administration of two radiopharmaceuticals under investigation: Part 1: [68Ga] Ga-DOTA-STR-17126 is used as a PET imaging tracer to identify tumour lesions with high expression of GRPR. Participants will receive a single intravenous bolus dose of 150+/-50MBq (50 micrograms) of DOTA-STR-17126 precursor. Part 2: Participants who have GRPR positive lesions identified by [68Ga] Ga-DOTA-STR-17126 PET imaging will receive a low Dose [177Lu] Lu-DOTA-STR-17126. Eligible participant(s) will receive 1.0+/-0.5GBq (50 microgram peptide) dose of [177Lu] Lu-DOTA-STR-17126, administered as a slow intravenous infusion. SPECT/CT scans will be performed to assess the biodistribution, dosimetry, and extrapolation of potential therapeutic dose potential of the radiopharmaceutical. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inclusion criteria refer to the enrolment of participants for the PET/CT and SPECT/CT imaging with the radioligands; PET imaging tracer [68Ga]Ga-DOTA-STR-17126 and with the SPECT imaging tracer [177Lu]Lu-DOTA-STR-17126. Participants must meet all of the following inclusion criteria to be eligible for enrolment.
- Ability to understand and willingness to provide informed consent
- Adults ≥ 18 years of age
- Must have the following histologically or cytologically confirmed diagnosis of advanced or metastatic i. breast cancer ii. prostate cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Key exclusion criteria (19 listed)
- Participants must not be enrolled into the trial if one or more of the following criteria are met. Participants must NOT meet any of the following Exclusion criteria to be eligible for enrolment:
- Known hypersensitivity to the investigational medicinal products (DOTA-STR-17126) or any of the excipients.
- Participants with Class 3 or 4 New York Heart Association (NYHA) Congestive Heart Failure.
- Average QTc (using the Fridericia correction calculation) > 470 msec for females and QTcF >450 msec for males on screening ECG or history of congenital long QT syndrome.
- Clinically significant bleeding within two weeks prior to trial entry (i.e., gastrointestinal bleeding, intracranial bleeding).
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 |
|---|---|---|
| [177Lu]Lu-DOTA-STR-17126Participants will receive a low dose of [177Lu]Lu-DOTA-STR-17126, dose activity: 1.0+/-0.5 GBq (50 micrograms peptide) of [177Lu]Lu-DOTA-STR-17126 precursor will be administered as a slow infusion. | Drug | [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu]Lu-DOTA-STR-17126 |
| [68Ga]Ga-DOTA-STR-17126Participants will receive a single intravenous bolus dose of 150+/-50MBq (25 - 50 micrograms) of [68Ga]Ga-DOTA-STR-17126 precursor. | Drug | [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu]Lu-DOTA-STR-17126 |
Primary outcome
Number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory parameters (hematology, blood chemistry, and urinalysis), abnormal Physical examinations findings
Time frame: Day 43
1. To evaluate adverse events (AEs) and serious adverse events (SAEs) by means of Common Toxicity Criteria Adverse Events (CTCAE version 5.0 Nov 2017); Assess occurrence and severity of AEs and SAEs; Monitor safety laboratory parameters (haematology, blood chemistry, and urinalysis) before, during and after IMP injections. The Common Terminology Criteria for Adverse Events (CTCAE) is a standardized, 1-5 severity grading system for classifying cancer treatment side effects (adverse events). Grades range from mild (1) to death (5). It is widely used in oncology to determine treatment safety, drug dosage modifications, and to document clinical trial toxicity
6 secondary outcomes
Standardized Uptake Value (SUV) of [⁶⁸Ga]Ga-DOTA-STR-17126
Time frame: Day 2 post-dose
PET/CT image quality of [⁶⁸Ga]Ga-DOTA-STR-17126
Time frame: Day 2 post-dose
Tumour to Background Ratio (TBR) of [⁶⁸Ga]Ga-DOTA-STR-17126
Time frame: Day 2 post-dose
Concentration of [68Ga]Ga-DOTA-STR-17126 and [177Lu]Lu-DOTA-STR-17126
Time frame: Day 1 post-dose, Day 2, Day 4, Day 8
Percentage of injected activity (%IA) in tumour and non-tumour organs
Time frame: Day 1 post-dose, Day 2, Day 4, Day 8
Calculation of absorbed dose (AD, mGy/MBq)
Time frame: Day 1 post-dose
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 10 Jun 2026.
- Individual participant dataSharing planned: Yes. Future use of research data Data collected during the study may be utilised in future research by the Principal Investigators, Sponsor and collaborating researchers to advance knowledge about cancer and its treatments. Proposals for access to trial data must be reviewed and approved by the PI. Participants in this study will be asked to grant advanced permission for the possible future sharing of the data collected in this study. Additional participant consent for use of the data will only be sought if it is a requirement of the HREC.
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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.
Duncan Colyer, RN BN PGDip contact
Nat Lenzo, MD principal investigator
Integrated Hematology Oncology Network (Icon Group)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [177Lu]Lu-DOTA-STR-17126 and [68Ga]Ga-DOTA-STR-17126 in people with Metastatic Breast Cancer and Metastatic Prostate Cancer, run by Integrated Haematology and Oncology Network at 1 site 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 11 inclusion and 19 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Amma P Owusu, RN BSc MN (+61498120411, research.iit@icon.team), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory parameters (hematology, blood chemistry, and urinalysis), abnormal Physical examinations findings (time frame: Day 43). 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 10 Jun 2026.