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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.

Phase 1/2RecruitingHao ZengNCT05808608Data as of May 2026

Treatment: AK104 · AxitinibThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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