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

Primary Purpose

Clear Cell Renal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ARO-HIF2

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARO-HIF2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 4 Hours (AUC0-4)

PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)

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)

PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUCinf)

PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2)

Systemic Clearance Derived From Intravenous Dose/Area Under the Plasma Concentration Versus Time Curve (CL)

Amount of Drug Excreted in the Urine Over One Dosing Interval Through 4 Hours Post- Dose (Ae, 0-4)

Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR)

Fraction Excreted (or Equivalently the Percent of Dose Excreted) in the Urine, Calculated by 100 X (Ae, 0-4 h/Dose)

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.

Duration of Response

Time to Response

Progression Free Survival

Overall Survival

Full Information

NCT ID

NCT04169711

First Posted

November 18, 2019

Last Updated

July 26, 2022

Sponsor

Arrowhead Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04169711

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

August 17, 2020 (Actual)

Primary Completion Date

January 24, 2022 (Actual)

Study Completion Date

July 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arrowhead Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clear Cell Renal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARO-HIF2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ARO-HIF2

Intervention Description

Multiple doses of ARO-HIF2 by intravenous infusion

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 2 years from first dose

Secondary Outcome Measure Information:

Title

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

Time Frame