None listed
Conditions
Brief summary
Brief description of the study purpose This is a first in human exploratory imaging study testing two new radioactive imaging agents designed to detect cancers that express a marker called the gastrin releasing peptide receptor (GRPR) in people with advanced or metastatic breast or prostate cancer. The study aims to assess safety, how the agents distribute in the body, radiation dose to organs and tumours, and how well they image cancer lesions. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older with advanced or metastatic breast or prostate cancer that has continued to progress despite standard treatments, who are well enough to take part in imaging scans. Study details Participants will receive one injection of a radioactive imaging tracer followed by multiple PET/CT scans on the same day. If their cancer shows uptake of the tracer, they may also receive a second, very low dose radioactive medicine followed by several SPECT/CT scans over the following days. Blood tests, vital signs checks, ECGs, and medical monitoring will be performed before and after the injections. The results from this study will help guide the future development of a GRPR targeted imaging and treatment approach, with the potential to improve how breast and prostate cancers are identified and treated in the future.
Interventions
In this study, participants receive one or two injections of radiopharmaceutical medicines that are designed to find cancer cells that carry a marker called GRPR (Gastrin-Releasing Peptide Receptor).
These medicines are called radiopharmaceuticals, which means they contain a very small amount of radioactivity that helps doctors take pictures of the cancer.
There are two parts to the intervention:
1. First Injection – Diagnostic Imaging Agent [68Ga]Ga-DOTA-STR-17126 (PET Scan Tracer).
This is th
In this study, participants receive one or two injections of radiopharmaceutical medicines that are designed to find cancer cells that carry a marker called GRPR (Gastrin-Releasing Peptide Receptor). These medicines are called radiopharmaceuticals, which means they contain a very small amount of radioactivity that helps doctors take pictures of the cancer. There are two parts to the intervention: 1. First Injection – Diagnostic Imaging Agent [68Ga]Ga-DOTA-STR-17126 (PET Scan Tracer). This is the first medicine every participant receives. It is given once by the Nuclear Medicine Physician or Nuclear Medicine Technologist as a quick injection into a vein (IV bolus). After the injection, participants have PET/CT scans at several time points (around 15, 30, 60, 120 and 180 minutes). Purpose: To show whether the cancer has GRPR receptors. To map where the cancer lesions are and how much of the tracer they absorb. To determine whether the participant can go on to the second injection. This tracer does not treat the cancer—its job is only to help visualise tumour sites. 2. Second Injection – Low-Dose Therapeutic/Imaging Agent [177Lu]Lu-DOTA-STR-17126 (SPECT Scan Tracer) Only participants whose PET scan shows “positive uptake” (meaning their tumours absorbed the first tracer) receive this second injection between Day 8 to Day 15, It is given once, as a slow infusion over about 20–30 minutes by the Nuclear Medicine Physician or Nuclear Medicine Technologist. After the infusion, participants have SPECT/CT scans at multiple times (about 30 minutes, 6 hours, 24 hours, Day 4, and Day 8). Purpose: To see how the medicine moves through the body. To understand how much radiation different organs and tumours absorb (dosimetry). To check safety and side effects. To help determine what dose might be used for future therapeutic studies. This is a very low dose of a therapy-type radiopharmaceutical, used only for imaging and safety assessment in this trial—not to treat the cancer. What Participants Are Exposed To: One radiopharmaceutical called ([68Ga]Ga-DOTA-STR-17126). If their cancer shows GRPR-positive uptake, participants receive a second radiopharmaceutical called ([177Lu]Lu-DOTA-STR-17126). The radiation exposure similar to standard nuclear medicine scans and considered low risk at the doses used. No chemotherapy, immunotherapy, or other experimental drugs are given as part of this study.
Sponsors
Icon (Integrated Cancer Oncology Network)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and willingness to provide informed consent 2. Adults 18 years of age 3. Must have the following histologically or cytologically confirmed diagnosis of advanced or metastatic i. breast cancer ii. prostate cancer 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 5. Participant must have clinical or radiological documented tumour progression as established by the Investigator within 30 days of signing consent for the study 6. 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 7. Participants must have adequate organ and bone marrow function, defined as follows: i. Absolute neutrophil count (ANC) equal to 1000 cells/mm3 ii. Platelet count equal to 100,000/mm3 iii. Haemoglobin equal to 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 times ULN in the presence of liver metastases v. Total bilirubin equal to 2 times upper limit of normal (ULN) vi. Creatinine equal to 2 times ULN and creatinine clearance (CrCL) equal to 60mL/min using the Cockcroft Gault equation (Appendix 2) 8. Able to remain still for up to 60 minutes per scan 9. Any other condition which, in the opinion of the Investigator, would preclude participation in this study
Exclusion criteria
1. Known hypersensitivity to the investigational medicinal products (DOTA-STR-17126) or any of the excipients. 2. Participants with Class 3 or 4 New York Heart Association (NYHA) Congestive Heart Failure. 3. 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. 4. Clinically significant bleeding within two weeks prior to trial entry (i.e., gastrointestinal bleeding, intracranial bleeding). 5. 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. 6. 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. 7. 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). 8. Has an additional active malignancy requiring therapy within the past 2 years. 9. 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: i. 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 10. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy within 30 days prior to trial enrolment. 11. Psychiatric illness/social situations that would interfere with compliance with study requirements. 12. Cannot undergo PET/CT scanning because of weight limits (350 lbs or 160 kg). 13. Prior exposure to any other GRPR-targeting therapeutic agents. 14. 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: i. 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. 15. 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). 16. Any clinically significant toxicity (with the exception of alopecia) related to prior anti-tumour therapy not resolved to Grade 1 or baseline.
Outcome results
None listed