Metastatic Clear Cell Renal Cell CarcinomaPhase 1PRadR2NCT07828249
Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma
A Phase 1 study testing 161Tb-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 study investigating the safety and clinical activity of 4 IV injections of 161Tb-PSMA-1 in patients with mccRCC. This trial is divided in 2 parts: The dose escalation part aims to assess the safety of 161Tb-PSMA-1 in up to 21 patients with mccRCC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Clear Cell Renal Cell Carcinoma
- What is being tested?
- 161Tb-PSMA-1 (radiopharmaceutical)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Nov 2029
- Phase
- 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 Any age
- All sexes
- No healthy volunteers
- Child, 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) progressing during or after at least 2 lines of therapy 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 positive PSMA-PET (68Ga-PSMA-PET) (see Appendix 6):
- For patient with only extrahepatic disease: ≥ 50% of positive extrahepatic 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 ≥ 6 months.
- I6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, with a Karnofsky Performance Status (KPS) ≥ 80%.
- I7. Adequate organ function according to laboratory values defined below:
- Haematological function :
- Peripheral absolute neutrophil count (ANC) ≥1.5 x 109 /L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL (without transfusion within 7 days)
- Renal and hepatic function :
- Serum creatinine or creatinine clearance according to CKD-EPI
- o ≤ 1.5 X upper limit of normal (ULN) OR ≥ 40 mL/min/1.73m2
- Total bilirubin
- o ≤ 1.5 X ULN with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled
- Aspartate aminotransferase (ASAT) and Alanine aminotransferase (ALAT) ≤ 1.5 X ULN (up to 3x ULN in case of liver metastases)
- I8. Women of child-bearing potential must have a negative pregnancy test at screening (within 72 hours prior C1D1) and must agree to use 1 highly 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 IMP. Effective forms of contraception are listed in Appendix 5.
- I9. Fertile males must use a highly effective contraception during dosing period and through 6 months after final administration of study.
- 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. Covered by a medical insurance.
Who cannot join
- E1. Patients with known active central nervous system (CNS) metastases and/or epidural metastases and/or leptomeningitis. 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.
- E3. Persisting AEs related to previous anti-cancer therapy which were not resolved to grade ≤ 1 (except: anemia provided that criterion I7 is met) and /or any persistent immune-related AEs >1 (except adequately controlled irAE, e.g.: with replacement therapy for endocrine irAE) using NCI CTCAE V6.0.
- 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 or 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.
- E6. Prior therapy or needs to be treated with a forbidden concomitant/concurrent therapies/procedures including (see protocol for minimal wash out period to C1D1 and use during treatment) :
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- Any anticancer treatment (immunotherapy, chemotherapy) or investigational therapy
- Targeted therapy including antiangiogenic therapy
- Radiotherapy
- Major surgery
- Growth factors targeting the myeloid lineage (e.g., G-CSF, GM-CSF, M-CSF) or growth factors targeting the erythroid lineage (e.g., erythropoietin)
- Live or live-attenuated vaccine. Note: killed vaccines are allowed.
- E7. Patients with clinically significant hematuria, hematemesis or hemoptysis exceeding 0.5 teaspoon (2.5mL) 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 for at least 2 weeks prior to C1D1.
- E8. Patients with an active uncontrolled infection.
- E9. Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Léon Bérard
Lyon, 69737
Anne-Laure GIRAUDET, MD, 04 78 78 20 21, annelaure.giraudet@lyon.unicancer.fr
Armelle VINCENEUX, MD, 04 26 55 68 33, armelle.vinceneux@lyon.unicancer.fr
About this study
Official title: PRadR2 - A Single Center, Open-label, Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma
This study is an open label, Phase I study investigating the safety and clinical activity of 4 IV injections of 161Tb-PSMA-1 in patients with mccRCC.
This trial is divided in 2 parts:
- The dose escalation part aims to assess the safety of 161Tb-PSMA-1 in up to 21 patients with mccRCC. Eligible patients will be treated with escalating activity of 161Tb-PSMA.
- The extension part aims to collect preliminary clinical activity data of the proposed treatment.
Read the detailed description
Patients with mccRCC will be selected, treated and followed-up as described below:
Selection step - 68Ga-PSMA PET:
A selection step at screening 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 according to eligibility criteria define din the protocol will be eligible to the treatment step.
Treatment step:
Eligible patients will be treated with escalating doses of 161Tb-PSMA-1 (from 7.4 GBq ± 10% to 11.5GBq ± 10%), intravenously (IV) for 4 cycles administered every 6 weeks. Three DL are expected to be assessed in the dose escalation part from 7.4 to 11.5 GBq ± 10%.
Dose Levels 161Tb-PSMA, IV, Q6W, 4 doses :
- DL-1 5.5 GBq ± 10% Q6W
- DL1 (starting activity) 7.4 GBq ± 10% Q6W
- DL2 9.5 GBq ± 10% Q6W
- DL3 11.5 GBq ± 10% Q6W
Assessment step:
To assess tumor response according to RECIST V1.1, imaging will be performed at baseline, W9-10, W24, then every 12 weeks up to 1 year after the first administration and every 24 weeks afterwards until progression, death 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. Moreover, to study the distribution of the 161Tb-PSMA-1 in standard organs and tumor lesions, repeated SPECT-CT acquisitions will be performed on all patients treated in the dose escalation part.
- Being tested
- 161Tb-PSMA-1 (radiopharmaceutical)
- Keywords
- radioligand, terbium, psma, mccRCC
- 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.
161Tb-PSMA-1 (radiopharmaceutical)Drug
161Tb-PSMA-1 (from 7.4 GBq ± 10% to 11.5GBq ± 10%), intravenously (IV) for 4 cycles administered every 6 weeks.
Dose Levels 161Tb-PSMA, IV, Q6W, 4 doses
- DL-1 5.5 GBq ± 10% Q6W
- DL1 (starting activity) 7.4 GBq ± 10% Q6W
- DL2 9.5 GBq ± 10% Q6W
- DL3 11.5 GBq ± 10% Q6W
| Study group | Role | What they receive |
|---|---|---|
| 161Tb-PSMA-1 | Experimental | Radiopharmaceutical - injectable solution Receives: Drug: 161Tb-PSMA-1 (radiopharmaceutical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-limiting toxicities (DLT)
Measured: During the first cycle of treatment (i.e., first 6 weeks)
Secondary outcomes (7)
Objective Response Rate at 24 weeks (ORR-24W)
Measured: 24 weeks after treatment start
Objective Response Rate (ORR)
defined as the rate of patients with a complete or partial response (CR or PR) according to RECIST v1.1.
Measured: Assessed through study completion, an average of 12 months.
Disease Control Rate after 24 weeks (DCR24w)
Measured: 24 weeks after treatment start
Best Overall Response Rate (BORR)
Measured: Assessed through study completion, an average of 12 months.
Duration of response (DOR)
Measured: From the date of first documented response until date of documented progression per RECIST 1.1 or death due to any cause, assessed through study completion, an average of 12 months.
Progression Free Survival (PFS)
Measured: From treatment start until the date of documented progression or death due to any cause, assessed through study completion, an average of 12 months.
Overall Survival (OS)
Measured: From treatment start to the date of death, assessed through study completion, an average of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828249
- Sponsor's protocol ID
- ET26-035
- Other IDs
- 2026-525526-38-00
- Acronym
- PRadR2
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRadR2 - A Single Center, Open-label, Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07828249
- Acronym / sponsor ID
- PRadR2 / ET26-035
- Keywords
- radioligand, terbium, psma, mccRCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 18 Sep 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 study is an open label, Phase I study investigating the safety and clinical activity of 4 IV injections of 161Tb-PSMA-1 in patients with mccRCC.
This trial is divided in 2 parts:
- The dose escalation part aims to assess the safety of 161Tb-PSMA-1 in up to 21 patients with mccRCC. Eligible patients will be treated with escalating activity of 161Tb-PSMA.
- The extension part aims to collect preliminary clinical activity data of the proposed treatment.
Detailed description
Patients with mccRCC will be selected, treated and followed-up as described below:
Selection step - 68Ga-PSMA PET:
A selection step at screening 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 according to eligibility criteria define din the protocol will be eligible to the treatment step.
Treatment step:
Eligible patients will be treated with escalating doses of 161Tb-PSMA-1 (from 7.4 GBq ± 10% to 11.5GBq ± 10%), intravenously (IV) for 4 cycles administered every 6 weeks. Three DL are expected to be assessed in the dose escalation part from 7.4 to 11.5 GBq ± 10%.
Dose Levels 161Tb-PSMA, IV, Q6W, 4 doses :
- DL-1 5.5 GBq ± 10% Q6W
- DL1 (starting activity) 7.4 GBq ± 10% Q6W
- DL2 9.5 GBq ± 10% Q6W
- DL3 11.5 GBq ± 10% Q6W
Assessment step:
To assess tumor response according to RECIST V1.1, imaging will be performed at baseline, W9-10, W24, then every 12 weeks up to 1 year after the first administration and every 24 weeks afterwards until progression, death 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. Moreover, to study the distribution of the 161Tb-PSMA-1 in standard organs and tumor lesions, repeated SPECT-CT acquisitions will be performed on all patients treated in the dose escalation part.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 161Tb-PSMA-1 | Experimental | Drug: 161Tb-PSMA-1 (radiopharmaceutical)Radiopharmaceutical - injectable solution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 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) progressing during or after at least 2 lines of therapy 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 positive PSMA-PET (68Ga-PSMA-PET) (see Appendix 6):
- I5. Life expectancy ≥ 6 months.
Key exclusion criteria (15 listed)
- E1. Patients with known active central nervous system (CNS) metastases and/or epidural metastases and/or leptomeningitis. 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.
- E3. Persisting AEs related to previous anti-cancer therapy which were not resolved to grade ≤ 1 (except: anemia provided that criterion I7 is met) and /or any persistent immune-related AEs >1 (except adequately controlled irAE, e.g.: with replacement therapy for endocrine irAE) using NCI CTCAE V6.0.
- 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 or 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.
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 |
|---|---|---|
| 161Tb-PSMA-1 (radiopharmaceutical)161Tb-PSMA-1 (from 7.4 GBq ± 10% to 11.5GBq ± 10%), intravenously (IV) for 4 cycles administered every 6 weeks. Dose Levels 161Tb-PSMA, IV, Q6W, 4 doses * DL-1 5.5 GBq ± 10% Q6W * DL1 (starting activity) 7.4 GBq ± 10% Q6W * DL2 9.5 GBq ± 10% Q6W * DL3 11.5 GBq ± 10% Q6W | Drug | 161Tb-PSMA-1 |
Primary outcome
Incidence of Dose-limiting toxicities (DLT)
Time frame: During the first cycle of treatment (i.e., first 6 weeks)
7 secondary outcomes
Objective Response Rate at 24 weeks (ORR-24W)
Time frame: 24 weeks after treatment start
Objective Response Rate (ORR)
Time frame: Assessed through study completion, an average of 12 months.
Disease Control Rate after 24 weeks (DCR24w)
Time frame: 24 weeks after treatment start
Best Overall Response Rate (BORR)
Time frame: Assessed through study completion, an average of 12 months.
Duration of response (DOR)
Time frame: From the date of first documented response until date of documented progression per RECIST 1.1 or death due to any cause, assessed through study completion, an average of 12 months.
Progression Free Survival (PFS)
Time frame: From treatment start until the date of documented progression or death due to any cause, assessed through study completion, an average of 12 months.
Overall Survival (OS)
Time frame: From treatment start to the date of death, assessed through study completion, an average of 12 months.
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 18 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 161Tb-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 25 inclusion and 15 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: opening soon, as of the sponsor's last update on 18 Sep 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 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.
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 Anne-Laure GIRAUDET, MD (04 78 78 20 21, anne-laure.giraudet@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-limiting toxicities (DLT) (time frame: During the first cycle of treatment (i.e., first 6 weeks)). 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 18 Sep 2026.