RecruitingPhase 1Phase 2NCT05808608

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

Sponsor

Hao Zeng

Enrollment

33 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma First-line Treatment

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. The primary endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of AK104 (a dual immune checkpoint blocker) and axitinib (a targeted drug) for people with rare or unusual subtypes of kidney cancer that don't respond well to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have a rare subtype of kidney cancer such as papillary, chromophobe, collecting duct, medullary, or sarcomatoid renal cell carcinoma - Your cancer has spread to other parts of the body (stage IV / metastatic) - You have not previously received systemic (whole-body) treatment for kidney cancer **You may NOT be eligible if...** - You have the most common type of kidney cancer (clear cell RCC) - You have previously received targeted therapy or immunotherapy for kidney cancer - You are too unwell to participate - You are younger than 18 or older than 75 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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