177LuPSMA in Renal Cell Carcinoma (NCT06964958) | Clinical Trial Compass
Active — Not RecruitingPhase 2
177LuPSMA in Renal Cell Carcinoma
United States24 participantsStarted 2025-07-31
Plain-language summary
This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC).
The name of the study drug involved in this research study is:
-177Lu-PSMA-617 (a type of radioligand therapy)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed advanced or metastatic renal cell carcinoma with a clear cell component. Patients with sarcomatoid histology are eligible.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
* Age ≥18 years.
* Prior receipt of at least one immune checkpoint inhibitor and at least one tyrosine kinase inhibitor in the neoadjuvant, adjuvant or metastatic settings. Prior treatment with Ra-223 is permitted providing that the last dose was ≥90 days prior to study entry.
* Presence of ≥1 PSMA-avid lesion (with uptake \> liver) on baseline/screening 68Ga-PSMA-11 PSMA-PET/CT (within 28 days of planned C1D1), and the absence of any measurable PSMA-negative lesions (i.e. nodal, soft tissue or visceral lesions \>1cm) on baseline/screening 68Ga-PSMA-11 PSMA-PET. All patients considered for the study should have their PSMA-PET imaging reviewed in a multidisciplinary meeting with Medical Oncology and Nuclear Medicine to confirm eligibility.
* ECOG performance status ≤2.
* Adequate organ and marrow function as per the below table:
* System Laboratory Value
* Hematologic
* ANC ≥ 1.5×109…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Tumor assessment will be performed every 12 weeks on treatment. Treatment duration is 36 weeks.