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A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma

NCT05256472 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-06

No results posted yet for this study

Summary

This is a Phase II, open-label trial to evaluate the efficacy and safety of AK104 monotherapy or AK104 in combination with axitinib as a first-line treatment for advanced/metastatic renal cell carcinoma (RCC). There are two parts in this trial. In part 1 of this study, subjects with unresectable advanced clear cell or non-clear cell renal cell carcinoma (ccRCC or nccRCC) who had not received systemic therapy for advanced disease will be enrolled to randomly received three different dosage of AK104 monotherapy. In part 2 of this study, subjects with unresectable advanced clear cell renal cell carcinoma (ccRCC) who had not received systemic therapy for advanced disease will be enrolled to receive AK104 plus Axitinib. All subjects will receive treatment until disease progression, development of unacceptable toxicity, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators.

Conditions

Interventions

DRUG

AK104

anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)

DRUG

axitinib

an oral, small molecule, TKI selective for VEGFRs 1, 2 and 3; 5mg bid orally

Sponsors & Collaborators

Principal Investigators

  • Dingwei Ye, MD · Shanghai Cancer Center of Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2025-12-31
Completion
2026-06-22

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05256472 on ClinicalTrials.gov