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A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma

NCT05808608 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-04-07

No results posted yet for this study

Summary

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.

Primary objective:

Phase Ib: To evaluate the safety and tolerability of different doses of cadonilimab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types to determine the recommended phase II dose (RP2D).

Phase II: To evaluate the objective response rate (ORR) of cadonilumab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types according to the RECIST 1.1 criteria.

Conditions

  • Renal Cell Carcinoma
  • First-line Treatment
  • Non Clear Cell Renal Cell Carcinoma
  • Sarcomatoid Renal Cell Carcinoma

Interventions

DRUG

AK104

Anti-PD-1/CTLA-4 bi-specific antibody drug; Phase 1b: 10mg/kg or 15mg/kg; Phase 2: RP2D intravenously (IV)

DRUG

Axitinib

An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally

Sponsors & Collaborators

  • Hao Zeng

    lead OTHER

Principal Investigators

  • Hao Zeng, Professor · West China Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808608 on ClinicalTrials.gov