Clinical trial · Interventional
Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma
NCT04169711CI-TRIAL-00096454completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARO-HIF2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARO-HIF2
- interventionNames
- Drug: ARO-HIF2
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
- timeFrame
- Up to 2 years from first dose
Secondary outcomes (16)
- measure
- Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- Up to Week 2: predose and up to 48 hours postdose
- measure
- PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.