NCT07469683

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

"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.

Detailed description

"Part 1 (Safety Run-in): The safety run-in phase consists of a single-arm cohort of SLC-3010 in combination with axitinib and will be conducted to determine the optimal dose of the SLC-3010 combination regimen before proceeding to phase 2. At each dose level of SLC-3010, 6 patients will be enrolled and the safety and tolerability will be assessed based on defined DLT criteria. The dose will be escalated or de-escalated stepwise based on the dose level identified from the SLC-3010-001 monotherapy dose-escalation cohort. In the safety run-in phase, the first patient enrolled at each dose level will be observed for safety for 48 hours (monitoring period) after administration. If the patient tolerates the treatment appropriately during this period, 5 additional patients may be enrolled. The starting dose in the safety run-in will be one dose level below the maximum tolerated dose (MTD) of SLC-3010 monotherapy verified in the SLC-3010-001 study(0.15mg/kg). The DLT observation period will be 21 days. If 1 or none of the 6 patients at the starting dose level experiences a DLT, the dose will be escalated to the next higher level. If DLTs are observed in 1 or fewer patients at the higher dose level, the dose will be escalated to the next level. If 2 out of the 6 patients at the starting dose level experience a DLT, the dose will be de-escalated to the next lower level. Upon completion of the safety run-in, the Data and Safety Monitoring Board (DSMB) will determine the MTD of SLC-3010 in combination with axitinib. This determination will consider safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) data. Part 2 (Phase 2): In Part 2, the anti-tumor activity and safety of SLC-3010 in combination with axitinib will be evaluated. Patients in Part 2 will receive treatment at the MTD identified during the safety run-in. A total of 60 patients (30 patients per group) will be enrolled and randomized after stratification based on prior treatment history with tyrosine kinase inhibitors (TKIs) including immune-oncology (IO) therapy including immune-oncology (IO) therapy (i.e., IO + IO versus IO + TKI). SLC-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.

Conditions

• Clear Cell Renal Cell Carcinoma
• Neoplasms
• Malignant Neoplasms
• Malignant Neoplasm of Kidney, Except Renal Pelvis

Interventions

Type	Name	Description
DRUG	SLC-3010 + Axitinib	SLC-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.
DRUG	Axitinib	Axitinib is a small molecule tyrosine kinase inhibitor. It will be administered orally at 5 mg twice daily

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: South Korea