OncoMatch/Clinical Trials/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
Is NCT07469683 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SLC-3010 + Axitinib and Axitinib for clear cell renal cell carcinoma.
Treatment: SLC-3010 + Axitinib · Axitinib — "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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — first-line recurrent/metastatic
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.
Must have received: anti-PD-L1 therapy — first-line recurrent/metastatic
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.
Cannot have received: IL-2-based drugs
Prior therapy using IL-2 (interleukin-2)-based drugs.
Cannot have received: axitinib (axitinib)
History of prior axitinib treatment.
Lab requirements
Blood counts
ANC ≥ 1500 cells/μL without G-CSF within 2 weeks prior to first dose. Platelet count ≥ 100,000/μL without transfusion within 2 weeks prior to screening. Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks prior to screening.
Kidney function
eGFR (CKD-EPI) ≥ 40 mL/min/1.73 m2.
Liver function
Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome), or if total bilirubin is > 1.5 × ULN, direct bilirubin ≤ ULN. AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with documented liver metastases). Albumin ≥ 2.8 g/dL.
Cardiac function
QTcF ≤ 480 msec at screening. No myocardial infarction, acute coronary syndrome, or history of coronary angioplasty/stenting/bypass grafting within 6 months. No CHF NYHA Class II-IV, or history of NYHA Class III or IV CHF.
Adequate organ functions as defined below. ... See full criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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