Clinical Research Directory

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

"This study is a phase 2, randomized study to evaluate the efficacy and safety of SLC-3010 in combination with axitinib versus axitinib monotherapy as second-line treatment in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC). This study includes a screening period, a treatment period, and a follow-up period. All patients will complete a screening period of up to 28 days. During the treatment period, patients will receive either SLC-3010 in combination with axitinib or axitinib monotherapy. Treatment may continue until the occurrence of unacceptable toxicity related to the study intervention, patient refusal for further participation, or disease progression. The patients will be followed up for disease progression and survival for up to 2 years after discontinuation of the study intervention, or until death, consent withdrawal, or the end of this clinical trial, whichever occurs first. For patients who withdraw consent, survival will be followed up via telephone or site visits every 2 months up to death or 12 months after the first administration of the last patient, whichever occurs first, depending on their consent for follow-up. This study consists of two parts: Part 1 is the safety run-in phase for SLC-3010 in combination with axitinib, and Part 2 is a randomized phase 2 trial to compare SLC-3010 in combination with axitinib and axitinib monotherapy.