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

NCT04169711 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AROHIF21001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment

  Up to 2 years from first dose

Secondary Outcomes (16)

• Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)

  Up to Week 2: predose and up to 48 hours postdose

• PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)

  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)

  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)

  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)

  Up to Week 2: predose and up to 48 hours postdose

Study Arms (1)

ARO-HIF2

EXPERIMENTAL

Drug: ARO-HIF2

Interventions

ARO-HIF2 DRUG

Multiple doses of ARO-HIF2 by intravenous infusion

ARO-HIF2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (5)

Research Site 1

Aurora, Colorado, 80045, United States

Location

Research Site 2

Las Vegas, Nevada, 89169, United States

Location

Research Site 4

Nashville, Tennessee, 37232, United States

Location

Research Site 5

Dallas, Texas, 75390, United States

Location

Research Site 6

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: August 17, 2020
• Primary Completion: January 24, 2022
• Study Completion: July 22, 2022
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (5)