Clear Cell Renal Cell CarcinomaPhase 1NCT04169711
Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
A Phase 1 study testing ARO-HIF2 in people with Clear Cell Renal Cell Carcinoma, run by Arrowhead Pharmaceuticals at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- ARO-HIF2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Aug 2020to 22 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site 1
Aurora, Colorado, 80045
Research Site 5
Dallas, Texas, 75390
Research Site 6
Houston, Texas, 77030
Research Site 2
Las Vegas, Nevada, 89169
Research Site 4
Nashville, Tennessee, 37232
About this study
Official title: A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
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).
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- ARO-HIF2
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-HIF2Drug
Multiple doses of ARO-HIF2 by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ARO-HIF2 | Experimental | Not described Receives: Drug: ARO-HIF2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Measured: Up to 2 years from first dose
Secondary outcomes (16)
Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)
Measured: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Terminal Elimination Half-Life (t1/2)
Measured: 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)
Measured: 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)
Measured: Up to Week 2: predose and up to 48 hours postdose
Renal Clearance Calculated by Ae, 0-4 h/AUC0-4h (CLR)
Measured: 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)
Measured: Up to Week 2: predose and up to 48 hours postdose
Overall Response Rate
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.
Measured: Baseline until disease progression, up to 2 years
Duration of Response
Measured: Baseline until disease progression, up to 2 years
Time to Response
Measured: Baseline until disease progression, up to 2 years
Progression Free Survival
Measured: up to 2 years
Overall Survival
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start17 Aug 2020
- Primary completion24 Jan 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169711
- Sponsor's protocol ID
- AROHIF21001
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2019
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04169711
- Acronym / sponsor ID
- AROHIF21001
- Conditions
- Clear Cell Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARO-HIF2 | Experimental | Drug: ARO-HIF2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARO-HIF2Multiple doses of ARO-HIF2 by intravenous infusion | Drug | ARO-HIF2 |
Primary outcome
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Time frame: Up to 2 years from first dose
16 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARO-HIF2 in people with Clear Cell Renal Cell Carcinoma, run by Arrowhead Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment (time frame: Up to 2 years from first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.