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).
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
Drug | Synonyms | Arms |
---|
ARO-HIF2 | | ARO-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
Name | Type | Description | Interventions |
---|
ARO-HIF2 | Experimental | | |
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