Actively Recruiting
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
Led by Yonsei University · Updated on 2026-03-13
78
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
"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.
CONDITIONS
Official 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 diagnosis of locally advanced or metastatic clear cell renal cell carcinoma (ccRCC).
- Part 1 (Safety Run-in): At least one first-line standard treatment for recurrent/metastatic disease.
- Part 2 (Phase 2): Prior first-line treatment with anti-PD-1 or anti-PD-L1 therapy.
- At least one measurable lesion by RECIST v1.1 criteria.
- Male or female patients aged 19 years or older at consent.
- Ability and willingness to provide written informed consent and comply with study procedures.
- Estimated life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function including blood counts, coagulation, kidney, and liver tests within defined limits.
- Any toxicities from prior therapies must have resolved to Grade 0 or 1, except certain endocrine events.
- Patients of childbearing potential must agree to use effective contraception during treatment and for 3 months after.
- Women of childbearing potential must have a negative pregnancy test before starting treatment or meet specific criteria for non-childbearing status.
You will not qualify if you...
- History of or active malignancy other than the target disease, except treated and non-recurring cancers.
- Known brain metastases or epidural disease unless treated and stable for at least 4 weeks.
- Diagnosis of immunodeficiency or recent use of systemic corticosteroids or immunosuppressants.
- Active autoimmune diseases requiring systemic treatment within the past 2 years.
- Known HIV, active hepatitis B or C infections.
- Active infections requiring systemic therapy.
- Significant cardiovascular diseases or recent serious heart events.
- Severe respiratory 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 or certain COVID-19 vaccine timing restrictions.
- Prior treatment with IL-2-based drugs or prior axitinib treatment.
- Inability to swallow oral medications or gastrointestinal disorders affecting absorption.
- Current use of potent CYP3A4 inducers or inhibitors that cannot be stopped.
- Recent significant bleeding or ongoing anticoagulation therapy beyond specified allowances.
- Serious wounds, dialysis requirement, organ transplantation, or symptomatic ascites.
- Known allergy to study drugs.
- Conditions or disorders that could increase risk or interfere with study participation.
- Psychiatric or substance abuse disorders affecting compliance.
- Pregnant or breastfeeding females.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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