Clinical Trials /

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

NCT04169711

Description:

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).

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: AROHIF21001
  • NCT ID: NCT04169711

Conditions

  • Clear Cell Renal Cell Carcinoma

Interventions

DrugSynonymsArms
ARO-HIF2ARO-HIF2

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
ARO-HIF2Experimental
  • ARO-HIF2

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Time Frame:Up to 2 years from first dose
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)
Time Frame:Up to Week 2: predose and up to 48 hours postdose
Safety Issue:
Description:
Measure:PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)
Time Frame:Up to Week 2: predose and up to 48 hours postdose
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2)
Time Frame:Up to Week 2: predose and up to 48 hours postdose
Safety Issue:
Description:
Measure:Systemic Clearance Derived From Intravenous Dose/Area Under the Plasma Concentration Versus Time Curve (CL)
Time Frame:Up to Week 2: predose and up to 48 hours postdose
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR)
Time Frame:Up to Week 2: predose and up to 48 hours postdose
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Overall Response Rate
Time Frame:Baseline until disease progression, up to 2 years
Safety Issue:
Description: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.
Measure:Duration of Response
Time Frame:Baseline until disease progression, up to 2 years
Safety Issue:
Description:
Measure:Time to Response
Time Frame:Baseline until disease progression, up to 2 years
Safety Issue:
Description:
Measure:Progression Free Survival
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arrowhead Pharmaceuticals

Last Updated

April 19, 2021