Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic … (NCT06059014) | Clinical Trial Compass
CompletedPhase 1/2
Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic Clear Cell Renal Cancer
France6 participantsStarted 2023-11-09
Plain-language summary
This study is an open label Phase I/II study conducted according to a Fleming design, investigating the safety and the efficacy of 4 IV injections of 177Lu-PSMA-1 in patients with metastatic clear cell renal cancer.
This trial is divided in 2 parts:
* A safety run-in part aiming to assess the safety of 177Lu-PSMA-1 (with 6 patients treated at the starting activity = 7.4 GBq of 177Lu-PSMA-1, every 6 weeks (Q6W) for 4 administrations). If more than one patient experiences a ST during the first cycle of therapy (6 weeks), then a lower activity of 177Lu-PSMA-1 will be evaluated in an additional cohort of 6 patients (5.9 GBq). The 6 patients from this safety run-in step, treated at the activity selected for phase II, will be included in the evaluation of Phase II part.
* A Phase II part aiming to assess the clinical activity of 177Lu-PSMA-1
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
I1. Male or female patients aged ≥ 18 years at time of informed consent signature.
I2. Patient with histologically confirmed diagnosis of metastatic clear cell renal cell carcinoma (mccRCC) previously treated by at least 2 lines of therapy in the advanced/metastatic setting including at least 1 line of anti-VEGFR and 1 line of immunotherapy.
I3. Patient with documented radiological disease progression at the time of inclusion with measurable disease as per RECIST v1.1.
I4. Patient with PSMA-PET positive lesions (68Ga-PSMA-PET):
* For patient with only extrahepatic disease: ≥ 50% of positive extrahepatic metastatic lesions
* For patient with both extra-hepatic and liver metastasis: ≥ 50% of positive extrahepatic metastatic lesions and ≥ 80 % of positive supracentimetric liver metastatic lesions.
* For patient with only liver metastatic lesions: ≥ 80 % of positive supracentimetric lesions.
I5. Life expectancy ≥ 3 months.
I6. Eastern Cooperative Oncology Group performance status 0, 1 or 2.
I7. Demonstrate adequate organ function as defined in the protocol.
I8. Women of child-bearing potential must have a negative urine pregnancy test at screening (within 72 hours prior C1D1) and must agree to use 1 effective form of contraception from the time of the treatment period and of the negative pregnancy test up to 6 months after the last administration of study drug. Effective forms of contraception are listed in the protocol.
I9. Fertile males must use hi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Severe Toxicities (ST) (for Phase1 part)
Timeframe: during the first 6 weeks of treatment
2
Disease Control Rate after 24 weeks of treatment (DCR24w) (for Phase II part)