Metastatic Clear Cell Renal Cell CarcinomaPhase 1/2PRadRNCT06059014
Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic Clear Cell Renal Cancer
A Phase 1/2 study testing 177Lu-PSMA-1 (radiopharmaceutical) in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Clear Cell Renal Cell Carcinoma
- What is being tested?
- 177Lu-PSMA-1 (radiopharmaceutical)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2023to 16 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 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.
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- 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 highly effective contraception during the dosing period and through 6 months after final administration of study drug.
- I10. Patient should be able and willing to comply with study visits and procedures as per protocol.
- I11. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
- I12. Patients must be covered by medical insurance.
Who cannot join
- E1. Patients with known active central nervous system (CNS) metastases and/or epidural metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses higher than 10 mg/d of methylprednisolone or equivalent) for at least 4 weeks prior to C1D1.
- E2. Patients previously treated with any radiopharmaceutical, excluding 68Ga-PSMA required during screening for this protocol.
- E3. Persisting toxicities related to previous anti-cancer therapy which were not resolved to grade ≤1 (except: anaemia provided that criterion I7 is met) and /or any persistent irAE of any grade (except adequately controlled irAE (e.g: with replacement therapy for endocrine irAE)).
- E4. History, within 2 years, of cancer other than renal cancer, except for basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer.
- E5. History of idiopathic pulmonary fibrosis, non-infectious pneumonitis, interstitial lung disease that required steroids or has current pneumonitis, interstitial lung disease, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- E6. Prior therapy or a need to be treated with a forbidden concomitant/concurrent therapies/procedure as defined per protocol.
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- E7. Patients with clinically significant hematuria, hematemesis, or hemoptysis exceeding 0.5 teaspoon (2.5 mL) of red blood, as well as those with a history of coagulopathy or other significant bleeding (e.g., pulmonary hemorrhage) within the 3 months prior to the initiation of the study treatment. Patients receiving anticoagulation medication will be eligible only if the dosage and route of administration have remained stable since at least 2 weeks prior to C1D1.
- E8. Patients with an active uncontrolled infection. E9. Women pregnant or breastfeeding. E10. Patients placed under a legal protection regimen such as: Judicial Safeguards, curatorship or guardianship
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentric, Single Arm, Open-label, Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic Clear Cell Renal Cancer
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
Read the detailed description
Despite the improvement in the management of metastatic clear-cell renal cell carcinoma (mccRCC) with antiangiogenic agent and immunotherapy, there is still an unmet need for patients who progress under these therapies. Indeed, there is currently no standard treatment for patients beyond the 2nd line of treatment in the advanced/metastatic setting. Prostate Specific Membrane Antigen (PSMA) is highly expressed in neovessels of various solid tumors including RCC: 86% of ccRCC.Higher grade and stage, metastatic and lethal ccRCC showed higher PSMA expression in tumor vessels, reflecting tumor prognosis. PSMA may be a target expressed in metastatic ccRCC for radionuclide therapy using PSMA Ligands Radiolabeled with Lutetium-177 (PRLT). 177Lu-PSMA delivers ß-particle radiation to PSMA-expressing cells and the surrounding microenvironment with demonstrated efficacy in metastatic prostate cancer. In multitreated prostate cancer patients, the additional effect of 177Lu-PSMA-617 compared to best standard of care alone led to a 4-month OS benefit, with an estimated 38% reduction in risk of death in the 177Lu-PSMA-617 arm compared to the best standard of care arm (median OS 15.3 months versus 11.3 months respectively, hazard ratio [HR]: 0.62, p<0.001).
A phase I/II study will be conducted to evaluate the tolerability and efficacy of 177Lu-PSMA-1 in patients presenting with a PSMA-positive mccRCC selected through 68Ga-PSMA PET. Only patients with tumor tracer uptake greater than background will be treated with 4 cycles of 7.4 GBq of 177Lu-PSMA-1 every 6 weeks.
This study is an open label Phase I/II study conducted according to a Fleming design, investigating the safety and the efficacy of 177Lu-PSMA-1 repeated cycles in patients with metastatic ccRCC.
The study is divided in 2 parts:
- A safety run-in part aiming to assess the safety of 177Lu-PSMA-1: The study will begin with a safety run-in of 6 patients treated with 7.4 GBq of 177Lu-PSMA1 [starting activity], IV, q6W for 4 administrations.
If more than one patient experiences severe toxicity during the first cycle, then a lower activity of 177Lu-PSMA-1 will be evaluated in an additional cohort of 6 patients (5.9 GBq).
The 6 patients enrolled in this safety run-in step treated at the selected activity 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
Patients will be treated and followed-up as following :
Selection step -68Ga-PSMA PET:
A selection step is mandatory for all patients in order to evaluate the PSMA expression in tumor lesions through 68Ga-PSMA PET and according to local imaging review. Only patients with PSMA expressing tumors will be eligible to the treatment step according eligbility
Treatment step:
Eligible patients will be treated with 177Lu-PSMA-1 (initial activity: 7.4 GBq), intravenously (IV) for 4 administrations every 6 weeks.
Assessment step:
To assess tumor response according to RECIST V1.1, imaging will be performed at baseline, at W9, at W24, then every 12 weeks up to 1 year after the first administration and then every 24 weeks until progression, death, loss to follow-up, or overall study completion, whichever is earliest. Survival status will be documented for all patients until death or overall study completion at least 12 months after the last patient.
- Being tested
- 177Lu-PSMA-1 (radiopharmaceutical)
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-PSMA-1 (radiopharmaceutical)Drug
7.4 GBq (or 5.9 GBq in case of lower actvity) of 177Lu-PSMA-1, every 6 weeks for 4 administirations
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-PSMA-1 | Experimental | Radiopharmaceutical - injectable solution Receives: Drug: 177Lu-PSMA-1 (radiopharmaceutical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe Toxicities (ST) (for Phase1 part)
Incidence of Severe Toxicities (ST) defined as specific adverse events (AEs) graded using NCI-CTCAE V5.0 occurring during the ST period (i.e. the 6 first weeks) and assessed as related to study drug and considered clinically significant. The sepcific adverse events are defined in the protocol.
Measured: during the first 6 weeks of treatment
Disease Control Rate after 24 weeks of treatment (DCR24w) (for Phase II part)
Disease Control Rate after 24 weeks of treatment (DCR24w) is defined as the rate of patients with a stable disease, a complete or partial response according to RECIST v1.1.after 24 weeks of treatment.
Measured: at 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start9 Nov 2023
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Clear Cell Renal Cell CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059014
- Sponsor's protocol ID
- ET22-313
- Acronym
- PRadR
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kryza D, Vinceneux A, Bidaux AS, Garin G, Tatu D, Cropet C, Badel JN, Perol D, Giraudet AL. A multicentric, single arm, open-label, phase I/II study evaluating PSMA targeted radionuclide therapy in adult patients with metastatic clear cell renal cancer (PRadR). BMC Cancer. 2024 Feb 1;24(1):163. doi: 10.1186/s12885-023-11702-8.
PubMed 38302933
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Single Arm, Open-label, Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic Clear Cell Renal Cancer
- ClinicalTrials.gov ID
- NCT06059014
- Acronym / sponsor ID
- PRadR / ET22-313
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 28 Sep 2023 (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 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
Detailed description
Despite the improvement in the management of metastatic clear-cell renal cell carcinoma (mccRCC) with antiangiogenic agent and immunotherapy, there is still an unmet need for patients who progress under these therapies. Indeed, there is currently no standard treatment for patients beyond the 2nd line of treatment in the advanced/metastatic setting. Prostate Specific Membrane Antigen (PSMA) is highly expressed in neovessels of various solid tumors including RCC: 86% of ccRCC.Higher grade and stage, metastatic and lethal ccRCC showed higher PSMA expression in tumor vessels, reflecting tumor prognosis. PSMA may be a target expressed in metastatic ccRCC for radionuclide therapy using PSMA Ligands Radiolabeled with Lutetium-177 (PRLT). 177Lu-PSMA delivers ß-particle radiation to PSMA-expressing cells and the surrounding microenvironment with demonstrated efficacy in metastatic prostate cancer. In multitreated prostate cancer patients, the additional effect of 177Lu-PSMA-617 compared to best standard of care alone led to a 4-month OS benefit, with an estimated 38% reduction in risk of death in the 177Lu-PSMA-617 arm compared to the best standard of care arm (median OS 15.3 months versus 11.3 months respectively, hazard ratio [HR]: 0.62, p<0.001).
A phase I/II study will be conducted to evaluate the tolerability and efficacy of 177Lu-PSMA-1 in patients presenting with a PSMA-positive mccRCC selected through 68Ga-PSMA PET. Only patients with tumor tracer uptake greater than background will be treated with 4 cycles of 7.4 GBq of 177Lu-PSMA-1 every 6 weeks.
This study is an open label Phase I/II study conducted according to a Fleming design, investigating the safety and the efficacy of 177Lu-PSMA-1 repeated cycles in patients with metastatic ccRCC.
The study is divided in 2 parts:
- A safety run-in part aiming to assess the safety of 177Lu-PSMA-1: The study will begin with a safety run-in of 6 patients treated with 7.4 GBq of 177Lu-PSMA1 [starting activity], IV, q6W for 4 administrations.
If more than one patient experiences severe toxicity during the first cycle, then a lower activity of 177Lu-PSMA-1 will be evaluated in an additional cohort of 6 patients (5.9 GBq).
The 6 patients enrolled in this safety run-in step treated at the selected activity 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
Patients will be treated and followed-up as following :
Selection step -68Ga-PSMA PET:
A selection step is mandatory for all patients in order to evaluate the PSMA expression in tumor lesions through 68Ga-PSMA PET and according to local imaging review. Only patients with PSMA expressing tumors will be eligible to the treatment step according eligbility
Treatment step:
Eligible patients will be treated with 177Lu-PSMA-1 (initial activity: 7.4 GBq), intravenously (IV) for 4 administrations every 6 weeks.
Assessment step:
To assess tumor response according to RECIST V1.1, imaging will be performed at baseline, at W9, at W24, then every 12 weeks up to 1 year after the first administration and then every 24 weeks until progression, death, loss to follow-up, or overall study completion, whichever is earliest. Survival status will be documented for all patients until death or overall study completion at least 12 months after the last patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-PSMA-1 | Experimental | Drug: 177Lu-PSMA-1 (radiopharmaceutical)Radiopharmaceutical - injectable solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- 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.
Key exclusion criteria (9 listed)
- E1. Patients with known active central nervous system (CNS) metastases and/or epidural metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses higher than 10 mg/d of methylprednisolone or equivalent) for at least 4 weeks prior to C1D1.
- E2. Patients previously treated with any radiopharmaceutical, excluding 68Ga-PSMA required during screening for this protocol.
- E3. Persisting toxicities related to previous anti-cancer therapy which were not resolved to grade ≤1 (except: anaemia provided that criterion I7 is met) and /or any persistent irAE of any grade (except adequately controlled irAE (e.g: with replacement therapy for endocrine irAE)).
- E4. History, within 2 years, of cancer other than renal cancer, except for basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer.
- E5. History of idiopathic pulmonary fibrosis, non-infectious pneumonitis, interstitial lung disease that required steroids or has current pneumonitis, interstitial lung disease, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
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-PSMA-1 (radiopharmaceutical)7.4 GBq (or 5.9 GBq in case of lower actvity) of 177Lu-PSMA-1, every 6 weeks for 4 administirations | Drug | 177Lu-PSMA-1 |
Primary outcome
Incidence of Severe Toxicities (ST) (for Phase1 part)
Time frame: during the first 6 weeks of treatment
Incidence of Severe Toxicities (ST) defined as specific adverse events (AEs) graded using NCI-CTCAE V5.0 occurring during the ST period (i.e. the 6 first weeks) and assessed as related to study drug and considered clinically significant. The sepcific adverse events are defined in the protocol.
Disease Control Rate after 24 weeks of treatment (DCR24w) (for Phase II part)
Time frame: at 24 weeks of treatment
Disease Control Rate after 24 weeks of treatment (DCR24w) is defined as the rate of patients with a stable disease, a complete or partial response according to RECIST v1.1.after 24 weeks of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 38302933Kryza D, Vinceneux A, Bidaux AS, Garin G, Tatu D, Cropet C, Badel JN, Perol D, Giraudet AL. A multicentric, single arm, open-label, phase I/II study evaluating PSMA targeted radionuclide therapy in adult patients with metastatic clear cell renal cancer (PRadR). BMC Cancer. 2024 Feb 1;24(1):163. doi: 10.1186/s12885-023-11702-8.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 177Lu-PSMA-1 (radiopharmaceutical) in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Centre Leon Berard at 1 site in France.
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 15 inclusion and 9 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: finished, as of the sponsor's last update on 24 Apr 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 France. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Toxicities (ST) (for Phase1 part) (time frame: during the first 6 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059014, which also lists 1 linked publication.
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 24 Apr 2026.