OncoMatch/Clinical Trials/NCT05808608
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
Is NCT05808608 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including AK104 and Axitinib for renal cell carcinoma.
Treatment: AK104 · Axitinib — This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
neutrophils ≥1.5*10^9, platelets ≥100*10^9, hemoglobin ≥90g/L
Kidney function
Serum creatinine ≤ 1.5 times of normal upper limit
Liver function
bilirubin ≤ normal upper limit 1.5 times, ALT/AST≤ normal upper limit 2.5 times
blood routine indexes: neutrophils ≥1.5*10^9, platelets ≥100*10^9, hemoglobin ≥90g/L; liver function: bilirubin ≤ normal upper limit 1.5 times, ALT/AST≤ normal upper limit 2.5 times;Serum creatinine ≤ 1.5 times of normal upper limit
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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