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

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

Inclusion Criteria9

  • age≥18, ≤75;
  • histology characteristics accord with special pathological subtypes of RCC: papillary renal cell carcinoma, chromophobic cell carcinoma, TFE3 rearrangement renal cell carcinoma, FH-deficient renal cell carcinoma, collecting duct carcinoma, medullary carcinoma, sarcomatoid carcinoma (\>10%), unclassified renal cell carcinoma ;
  • metastatic renal cell carcinoma (TNM IV stage according to the 2009 TNM Staging system).
  • Patients who have not previously received systemic therapy, ECOG (Eastern Cooperative Oncology Group)≤2;
  • expected survival \>3 months;
  • all patients signed informed consent.
  • blood routine indexes: neutrophils ≥1.5\*109, platelets ≥100\*109, 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
  • the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.

Exclusion Criteria10

  • other malignancies previously or at the same time that are different from the primary site or histology of the tumor assessed in this study, except cervical carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (Ta, Tis, T1) or other malignancies that occurred before the enrollment and have been cured for more than 3 years;
  • renal decompensation requires hemodialysis or peritoneal dialysis;
  • arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction), nearly six months, or congestive heart failure than NYHA Ⅱ level; Hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg) that has been treated with 2 or more antihypertensive treatments and still cannot be controlled;
  • severe active clinical infection;
  • patients with coagulation disorder or bleeding constitution;
  • major surgery or severe trauma was performed within 4 weeks before enrollment;
  • a history of allogeneic organ transplantation or bone marrow transplantation;
  • drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;
  • known or suspected allergy to the study drug;
  • those who received treatment other than this study within 4 weeks prior to and during the study period.

Interventions

DRUGAK104

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

DRUGAxitinib

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


Locations(1)

West China Hospital

Chengdu, Sichuan, China

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NCT05808608


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