A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
Chugai Pharmaceutical
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years at time of signing Informed Consent Form (ICF) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part) * Refractory or resistant to standard therapies or standard therapies are not available Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study or within 27 weeks after the last dose of AUBE00 or within 2 months after the last dose of cetu…
Interventions
- DrugAUBE00
AUBE00 as an oral administration
- DrugCetuximab
Cetuximab as an IV infusion
Locations (4)
- South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, Michigan
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- National Cancer Center Hospital EastKashiwa, Chiba
- National Cancer Center HospitalChuo-ku, Tokyo