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 Adaptive 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 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 anticancer therapy

          -  Has received systemic therapy or radiation therapy within 2 weeks prior to screen

          -  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

          -  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
      
Maximum Eligible Age:75 Years
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 8: 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 8: 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 8: 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 8: 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 8: predose and up to 48 hours postdose
Safety Issue:
Description:
Measure:Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumors V1.1 Criteria (Overall Response Rate)
Time Frame:Baseline until disease progression, up to 2 years
Safety Issue:
Description:

Details

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

Last Updated

August 20, 2020