Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169711
• Other study ID #: AROHIF21001
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2020
• Est. completion date: July 22, 2022

Study information

• Verified date: July 2022
• Source: Arrowhead Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 22, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception

• Willing to provide written informed consent and to comply with study requirements

• Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma that has progressed during or after at least two prior therapeutic regimens which must include vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint inhibitor therapy or that has otherwise failed such therapies, is measurable disease per RECIST 1.1 criteria, is biopsy accessible

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

• Estimated life expectancy of longer than 3 months

• Adequate organ function at screening

Exclusion Criteria:

• History of untreated brain metastasis or leptomeningeal disease or spinal cord compression

• Failure to recover from reversible effects of prior anti-cancer therapy

• Has received systemic therapy or radiation therapy within 2 weeks prior to first dose

• History of solid organ or stem cell transplantation

• Current use of anti-VEGF or mammalian target of rapamycin (mTOR) agents, or chronic immunosuppressive therapy

• Any prior use of hypoxia inducible factor 2 (HIF2) inhibitors within 6 months prior to first dose

• Current use of immune checkpoint inhibitors

• Use of an investigational agent or device within 2 weeks prior to dosing, or current participation in an investigational study

• Known HIV, hepatitis B or hepatitis C

• History of other clinically meaningful disease

• Major surgery within 4 weeks of Screening

• Active malignancy requiring therapy other than ccRCC within 3 years of study entry

Note: Other eligibility criteria may apply per protocol.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Drug:
• ARO-HIF2
Multiple doses of ARO-HIF2 by intravenous infusion

Locations

Country	Name	City	State
United States	Research Site	Aurora	Colorado
United States	Research Site	Dallas	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment		Up to 2 years from first dose
Secondary	Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)		Up to Week 2: predose and up to 48 hours postdose
Secondary	PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)		Up to Week 2: predose and up to 48 hours postdose
Secondary	PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 4 Hours (AUC0-4)		Up to Week 2: predose and up to 48 hours postdose
Secondary	PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)		Up to Week 2: predose and up to 48 hours postdose
Secondary	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)		Up to Week 2: predose and up to 48 hours postdose
Secondary	PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUCinf)		Up to Week 2: predose and up to 48 hours postdose
Secondary	PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2)		Up to Week 2: predose and up to 48 hours postdose
Secondary	Systemic Clearance Derived From Intravenous Dose/Area Under the Plasma Concentration Versus Time Curve (CL)		Up to Week 2: predose and up to 48 hours postdose
Secondary	Amount of Drug Excreted in the Urine Over One Dosing Interval Through 4 Hours Post- Dose (Ae, 0-4)		Up to Week 2: predose and up to 48 hours postdose
Secondary	Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR)		Up to Week 2: predose and up to 48 hours postdose
Secondary	Fraction Excreted (or Equivalently the Percent of Dose Excreted) in the Urine, Calculated by 100 X (Ae, 0-4 h/Dose)		Up to Week 2: predose and up to 48 hours postdose
Secondary	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.	Baseline until disease progression, up to 2 years
Secondary	Duration of Response		Baseline until disease progression, up to 2 years
Secondary	Time to Response		Baseline until disease progression, up to 2 years
Secondary	Progression Free Survival		up to 2 years
Secondary	Overall Survival		up to 2 years