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

NCT07469683 | Recruiting Phase 2

• 1 other identifier: 4-2024-1664
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate, ORR (PART2)

  Comparative evaluation of the efficacy of SLC-3010 in combination with axitinib versus axitinib monotherapy

  after 3 years

Secondary Outcomes (4)

• Duration of response (DOR)

  after 3 years

• Disease control rate (DCR)

  after 3 years

• Progression-free survival (PFS)

  after 3 years

• Overall survival (OS)

  after 3 years

Study Arms (2)

SLC-3010+ Axitinib

EXPERIMENTAL

SLC-3010+ Axitinib administration arm

Drug: SLC-3010 + Axitinib

Axitinib

ACTIVE COMPARATOR

Axitinib administration arm

Drug: Axitinib

Interventions

SLC-3010 + Axitinib DRUG

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.

SLC-3010+ Axitinib

Axitinib DRUG

Axitinib is a small molecule tyrosine kinase inhibitor. It will be administered orally at 5 mg twice daily

Axitinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Estimated life expectancy of ≥ 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate organ functions as defined below. System organ class Laboratory test results
• \- Hematology
• : Absolute neutrophil count (ANC) ≥ 1500 cells/μL without the support of granulocyte colony-stimulating factor (G-CSF) within 2 weeks prior to the first dose of the study intervention.
• Platelet count ≥ 100,000/μL without the support of transfusion within 2 weeks prior to screening laboratory sample collection.
• Hemoglobin ≥ 9 g/dL without the support of transfusion within 2 weeks prior to screening laboratory sample collection.
• Coagulation
• :International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × the upper limit of normal (ULN). If the patient is receiving anticoagulant therapy, PT shall be within the therapeutic range for the intended use of anticoagulants.

You may not qualify if:

• 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.
• Note: Chronic use of ≤ 10 mg/day of prednisone or equivalent may be allowed after discussion and approval by the lead institution.
• Active autoimmune disease that has required systemic treatment (e.g., disease controllers, corticosteroids, or immunosuppressive drugs) within the recent 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal insufficiency or hypopituitarism) is not considered a form of systemic treatment.
• Known infection with Human Immunodeficiency Virus-1 (HIV-1) or HIV-2. Known active hepatitis B virus infection (i.e., HBsAg positive) or hepatitis C virus infection (e.g., \[qualitatively\] detectable HCV RNA). Patients with a negative HCV RNA test after a positive HCV antibody test and no ongoing anti-HCV therapy.
• Active infection requiring systemic therapy.
• Significant cardiovascular diseases, including but not limited to: Stable arrhythmias medically controlled with ongoing medication are allowed.
• QT interval (Interval from the start of the Q wave to the end of the T wave of the ECG) corrected for heart rate using Fridericia's formula (QTcF) \> 480 msec at screening
• Myocardial infarction, acute coronary syndrome, or history of coronary angioplasty/stenting/bypass grafting within the recent 6 months.
• Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II-IV, or a history of NYHA Class III or IV CHF.
• Patients with significant respiratory symptoms, known or suspected serious or severe pulmonary conditions at screening, or requiring supplemental oxygen.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

KR (1)