Trials / Recruiting
RecruitingNCT07030959
Study of AUBE00 in Patients With Solid Tumors
A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.The total number of patients in this study will be approximately 90 to 130.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AUBE00 | AUBE00 as an oral administration |
| DRUG | Cetuximab | Cetuximab as an IV infusion |
Timeline
- Start date
- 2025-06-05
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
- First posted
- 2025-06-22
- Last updated
- 2026-02-25
Locations
4 sites across 2 countries: United States, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07030959. Inclusion in this directory is not an endorsement.