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
Recruiting · Phase 2 · Yonsei University · registry updated 2026-03-13
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
"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....
Inclusion
- 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.
- Male or female patients aged ≥ 19 years at the date on which the informed consent is signed.
- Ability and willingness to provide written informed consent and to comply with all study procedures.
Exclusion
- History of malignancy or active malignancy other than the target disease in this study. Exceptions are as follows:
- 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.
- Diagnosis of immunodeficiency or current use of chronic systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first administration of the study intervention. Topical (\< Grade III), inhaled corticosteroids, or intra-articular corticosteroids, topical creams/lotions, mouthwashes containing corticosteroids, or mineralocorticoids (e.g., fludrocortisone) are allowed.