Actively Recruiting
An Open-label, Randomized Phase 2 Trial Evaluating SLC-3010 Plus Axitinib Versus Axitinib Alone as Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Led by Yonsei University · Updated on 2026-03-13
78
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic clear cell renal cell carcinoma.
- For safety run-in phase: At least one first-line treatment of standard care in the recurrent/metastatic setting.
- For phase 2: Prior anti-PD-1 or anti-PD-L1 monotherapy or combination therapy as first-line treatment.
- At least one measurable lesion by RECIST v1.1.
- Male or female aged 19 years or older.
- Ability and willingness to provide written informed consent and comply with study procedures.
- Estimated life expectancy of at least 3 months.
- ECOG performance status of 0 or 1.
- Adequate organ function based on blood counts, liver, kidney, and coagulation tests.
- Resolved prior therapy toxicities to grade 0 or 1, with exceptions for certain manageable side effects.
- Agreement to use highly effective contraception during treatment and for 3 months after.
- Negative pregnancy test for women of childbearing potential or confirmed non-childbearing status.
You will not qualify if you...
- History of or active malignancies other than the target disease except certain treated cancers.
- Known brain metastases or epidural conditions unless stable and treated.
- Immunodeficiency or recent use of systemic immunosuppressants.
- Active autoimmune disease requiring recent systemic treatment.
- Known active infections including HIV, hepatitis B or C.
- Active infection requiring systemic therapy.
- Significant cardiovascular diseases or arrhythmias beyond specified limits.
- Severe pulmonary conditions or need for supplemental oxygen.
- Recent systemic anticancer therapy or participation in other investigational trials.
- Recent radiotherapy or major surgery without recovery.
- Recent live vaccine administration.
- Prior IL-2 therapy or axitinib treatment.
- Inability to swallow oral drugs or gastrointestinal disorders affecting absorption.
- Current use of certain potent CYP3A4 inducers or inhibitors that cannot be stopped.
- Recent significant bleeding or use of certain anticoagulants beyond allowed exceptions.
- Clinically significant diseases including unhealed wounds, dialysis requirement, organ transplantation, or symptomatic ascites.
- Known allergies to study drugs or their analogs.
- Conditions or treatments that may pose risk or interfere with study participation.
- Psychiatric or substance abuse disorders affecting compliance.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks per dose level
Participants in the safety run-in phase receive escalating doses of SLC-3010 combined with axitinib to determine the optimal dose. The first patient at each dose level is monitored for safety for 48 hours before additional patients are enrolled. Dose-limiting toxicities are assessed during a 21-day observation period.
Multiple visits during the 21-day dose-limiting toxicity observation period
Duration - Multiple 21-day cycles until disease progression or discontinuation
Participants receive either SLC-3010 combined with axitinib or axitinib alone as a second-line treatment for locally advanced or metastatic clear cell renal cell carcinoma. SLC-3010 is given by intravenous infusion on Day 1 of each 21-day cycle, and axitinib is taken orally twice daily continuously.
Visits at the start of each 21-day cycle
Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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