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

"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

Trial Details

NCT ID
NCT07469683
Phase
PHASE2
Sponsor
Yonsei University
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • SLC-3010 + Axitinib
  • Axitinib
Locations (sample)
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • 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 …
  • At least one measurable lesion as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.

For full eligibility, visit ClinicalTrials.gov.

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