NCT03746431
Who may be able to join
Who might be able to join this trial:
- You have been confirmed by a lab test to have an advanced solid tumour cancer that has not responded to standard treatments, has no standard treatments available, or you have chosen not to have standard treatment.
- Your cancer can be measured or tracked using standard imaging scans.
- You are generally well enough to carry out light activity and care for yourself (your doctor will assess this using a standard scale).
- Your doctor believes you are likely to live for more than 3 months.
- There is tumour tissue available from either a previous biopsy or a new one, which can be tested in a lab (this does not need to be sent in before you join).
- Your heart, kidneys, and liver are working well enough to participate.
- Your blood counts are at an acceptable level, showing your bone marrow is functioning adequately.
- You are able to understand and are willing to sign a consent form agreeing to take part.
- (For Phase 2 of the trial only) Your cancer is one of the following specific types: endometrial, cervical, ovarian, triple-negative breast cancer, HER2-negative breast cancer, head and neck squamous cell carcinoma, adenoid cystic carcinoma, or uveal melanoma — and it is advanced, has spread, cannot be removed by surgery, or has come back.
- (For Phase 2 only) Your cancer has not responded to standard treatment, or no standard treatment exists or is suitable for you.
- Before receiving the treatment, a special imaging scan must show that at least one area of your cancer has enough of a specific protein target for the treatment to work.
Who may not be able to join:
- You have received a radioactive drug used as a cancer treatment within the last 6 months.
- You are unable to have the required imaging scans for any reason — for example, if you cannot lie flat for the length of the scan.
- You have cancer that has spread to the brain and is not currently under control, or requires treatment with steroids, surgery, or radiation.
- You have had any cancer treatment (including experimental treatments) or external radiation therapy within the 14 days before your first imaging scan for this trial.
- You have another cancer that is growing or has needed active treatment within the past 3 years (though certain skin cancers or early-stage cancers that have been successfully treated may still be eligible — confirm with trial site).
- You still have significant side effects (rated moderate or above) from a previous cancer treatment, except for moderate hair loss.
- You have previously had an organ transplant, including a bone marrow or stem cell transplant.
- You have previously been treated with certain specific chemotherapy drugs called nitrosoureas or actinomycin-D.
- You have a clinically significant amount of protein in your urine (confirm with trial site).
- You have a known or suspected allergy or sensitivity to the drugs used in this trial or any of their ingredients.
- You have other serious uncontrolled health conditions, such as an active infection, uncontrolled heart failure, unstable chest pain, an irregular heartbeat, uncontrolled diabetes, or a mental health or personal situation that would make it hard to follow the trial requirements.
- You have previously received more than 20 Gray (a unit of radiation dose) of radiation to large parts of your bone marrow.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Dose Escalation: Incidence of adverse events (AEs).; Single-Dose Escalation: Incidence of dose limiting toxicities (DLTs).; Multi-Dose Escalation: Incidence of DLTs.; Dose Escalation: Incidence of clinically significant clinical laboratory abnormalities.; Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals).; Cold Antibody Sub-Study: Changes in uptake of [111In]-FPI-1547 Injection following FPI-1175 Infusion in selected regions of interest on SPECT/CT images.; Cold Antibody Sub-Study: Changes in radiation dose estimates for selected tissues, organs an...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.