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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 : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Drug: ARO-HIF2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022


Arm Intervention/treatment
Experimental: ARO-HIF2 Drug: ARO-HIF2
Multiple doses of ARO-HIF2 by intravenous infusion




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to 2 years from first dose ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  2. PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  8. 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 ]
  9. 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 ]
  10. Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR) [ Time Frame: Up to Week 2: predose and up to 48 hours postdose ]
  11. 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 ]
  12. 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.

  13. Duration of Response [ Time Frame: Baseline until disease progression, up to 2 years ]
  14. Time to Response [ Time Frame: Baseline until disease progression, up to 2 years ]
  15. Progression Free Survival [ Time Frame: up to 2 years ]
  16. Overall Survival [ Time Frame: up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 anticancer 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169711


Contacts
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Contact: Medical Monitor 1-626-304-3400 clinicaltrials@arrowheadpharma.com

Locations
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United States, Colorado
Research Site Recruiting
Aurora, Colorado, United States, 80045
United States, Nevada
Research Site Recruiting
Las Vegas, Nevada, United States, 89169
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site Recruiting
Dallas, Texas, United States, 75390
Research Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Arrowhead Pharmaceuticals
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04169711    
Other Study ID Numbers: AROHIF21001
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases