Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma

NCT07828249 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: ET26-0352026-525526-38-00
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

radioligand; terbium; psma; mccRCC

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-limiting toxicities (DLT)

  During the first cycle of treatment (i.e., first 6 weeks)

Secondary Outcomes (7)

• Objective Response Rate at 24 weeks (ORR-24W)

  24 weeks after treatment start

• Objective Response Rate (ORR)

  Assessed through study completion, an average of 12 months.

• Disease Control Rate after 24 weeks (DCR24w)

  24 weeks after treatment start

• Best Overall Response Rate (BORR)

  Assessed through study completion, an average of 12 months.

• Duration of response (DOR)

  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.

Study Arms (1)

161Tb-PSMA-1

EXPERIMENTAL

Radiopharmaceutical - injectable solution

Drug: 161Tb-PSMA-1 (radiopharmaceutical)

Interventions

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

161Tb-PSMA-1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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

You may not qualify if:

• 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) :
• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69737, France

Location

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

Interventions

Radiopharmaceuticals

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals

Central Study Contacts

Anne-Laure GIRAUDET, MD

CONTACT

04 78 78 20 21; anne-laure.giraudet@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)