"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.
Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ccRCC.
Part 1 (Safety Run-in): At least one first-line treatment of standard of care in the recurrent/metastatic setting.
Part 2 (Phase 2): Anti-PD-1 (Programmed Cell Death Protein 1) or anti-PD-L1 (Programmed Cell Death-Ligand 1) monotherapy or combination therapy as first-line treatment in the recurrent/metastatic setting.
At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.
Malignancies that have been treated with curative intent and have not recurred within the recent 2 years.
Completely resected basal cell carcinoma or squamous cell carcinoma of the skin.
Any type of completely resected carcinoma in situ.
Known brain metastases or epidural conditions. However, patients who have been sufficiently treated with radiotherapy and/or surgery (including radiosurgery) and have been stable for at least 4 weeks prior to the first administration of the study intervention can be enrolled. Note: Patients with an incidental finding of a single lesion <1 cm may be eligible if deemed not to require treatment at the discretion of the investigator. Eligible patients shall be neurologically asymptomatic and shall not have received corticosteroid therapy for at least 2 weeks prior to the first administration of the study intervention.
Parallel
SLC-3010 + Axitinib
DrugSLC-3010 will be administered via intravenous (IV) infusion at the defined dose on Day 1 of each 21-day cycle, and the infusion rate will be 100 mL/hour throughout each cycle. If the patient tolerates the first cycle, SLC-3010 may be administered over 30 minutes in subsequent cycles (100 mL/30 min). Axitinib is a small molecule tyrosine kinase inhibitor. It will be administered orally at 5 mg twice daily regardless of the timing of SLC-3010 administration.
Axitinib
DrugAxitinib is a small molecule tyrosine kinase inhibitor. It will be administered orally at 5 mg twice daily
Overall Response Rate, ORR (PART2)
Comparative evaluation of the efficacy of SLC-3010 in combination with axitinib versus axitinib monotherapy
Duration of response (DOR)
Disease control rate (DCR)
Progression-free survival (PFS)
Overall survival (OS)
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