The purpose of this study is to evaluate the safety and efficacy of ARO-HIF2 injection (also referred to as ARO-HIF2) and to determine the recommended Phase 2 dose in the treatment of patients with advanced clear cell renal cell carcinoma (ccRCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Multiple doses of ARO-HIF2 by intravenous infusion
Research Site 1
Aurora, Colorado, United States
Research Site 2
Las Vegas, Nevada, United States
Research Site 4
Nashville, Tennessee, United States
Research Site 5
Dallas, Texas, United States
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Time frame: Up to 2 years from first dose
Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 4 Hours (AUC0-4)
Time frame: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Time frame: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Measurable Concentration at a Time=t, Using a Specified Trapezoidal Rule (AUC0-t)
Time frame: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUCinf)
Time frame: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2)
Time frame: Up to Week 2: predose and up to 48 hours postdose
Systemic Clearance Derived From Intravenous Dose/Area Under the Plasma Concentration Versus Time Curve (CL)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site 6
Houston, Texas, United States
Time frame: Up to Week 2: predose and up to 48 hours postdose
Amount of Drug Excreted in the Urine Over One Dosing Interval Through 4 Hours Post- Dose (Ae, 0-4)
Time frame: Up to Week 2: predose and up to 48 hours postdose
Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR)
Time frame: Up to Week 2: predose and up to 48 hours postdose
Fraction Excreted (or Equivalently the Percent of Dose Excreted) in the Urine, Calculated by 100 X (Ae, 0-4 h/Dose)
Time frame: Up to Week 2: predose and up to 48 hours postdose
Overall Response Rate
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria.
Time frame: Baseline until disease progression, up to 2 years
Duration of Response
Time frame: Baseline until disease progression, up to 2 years
Time to Response
Time frame: Baseline until disease progression, up to 2 years
Progression Free Survival
Time frame: up to 2 years
Overall Survival
Time frame: up to 2 years