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

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ClinicalTrials.gov Identifier: NCT04169711
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 18, 2019
First Posted Date  ICMJE November 20, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE August 17, 2020
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to 2 years from first dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to 2 years from first dose ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 2 years from first dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
  • Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  • PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 Infinity (AUCinf) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  • PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  • 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 ]
  • 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 ]
  • Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  • 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 ]
  • Overall Response Rate [ Time Frame: Baseline until disease progression, up to 2 years ]
    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 Frame: Baseline until disease progression, up to 2 years ]
  • Time to Response [ Time Frame: Baseline until disease progression, up to 2 years ]
  • Progression Free Survival [ Time Frame: up to 2 years ]
  • Overall Survival [ Time Frame: up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to Week 8: predose and up to 48 hours postdose ]
  • PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Up to Week 8: 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) [ Time Frame: Up to Week 8: predose and up to 48 hours postdose ]
  • 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 ]
  • PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2) [ Time Frame: Up to Week 8: predose and up to 48 hours postdose ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
Official Title  ICMJE A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Clear Cell Renal Cell Carcinoma
Intervention  ICMJE Drug: ARO-HIF2
Multiple doses of ARO-HIF2 by intravenous infusion
Study Arms  ICMJE Experimental: ARO-HIF2
Intervention: Drug: ARO-HIF2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2021)
50
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2019)
40
Estimated Study Completion Date  ICMJE March 30, 2022
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical Monitor 1-626-304-3400 clinicaltrials@arrowheadpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04169711
Other Study ID Numbers  ICMJE AROHIF21001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Arrowhead Pharmaceuticals
Study Sponsor  ICMJE Arrowhead Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arrowhead Pharmaceuticals
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP