Phase 2 Study Comparing Combination of SLC-3010 and Axitinib Versus Axitinib Alone for Advanced or Metastatic Clear Cell Kidney Cancer

What this Trial Is About

Researchers are investigating the effectiveness and safety of combining SLC-3010 with axitinib compared to using axitinib alone as a second-line treatment for patients with locally advanced or metastatic clear cell renal cell carcinoma ccRCC. This phase 2 study includes a safety run-in phase to find the best dose and a randomized phase to compare the combination therapy against axitinib monotherapy. The study aims to provide new treatment options for patients with advanced kidney cancer who have received prior therapies. The study has two parts. In the safety run-in phase, SLC-3010 is given with axitinib to small groups of patients to determine the optimal dose by monitoring safety and side effects. In the randomized phase, 60 patients will be assigned to receive either the combination of SLC-3010 given as an intravenous infusion every 21 days plus oral axitinib twice daily, or axitinib alone. Treatment continues until side effects become unacceptable, the disease progresses, or the patient decides to stop. Participants will undergo screening for up to 28 days before treatment starts. During the study, researchers will assess tumor response and safety measures. After stopping treatment, patients will be followed for disease progression and survival for up to two years or until death or withdrawal. Outcome measures include overall response rate, duration of response, disease control rate, progression-free survival, and overall survival. Regular monitoring will ensure patient safety and collect important data throughout the study period.

An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma