Study of AUBE00 in Patients With Solid Tumors

Purpose

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.

Condition

  • Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 cetuximab, whichever is longer. - Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) - Significant cardiovascular disease, such as New York Heart Association (NYHA) Class II or greater cardiac disease, unstable angina, or myocardial infraction within the previous 6 months or unstable arrhythmias within the previous 3 months - Patient with complications from a cerebrovascular disorder (such as subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, etc.) or a history of such complications within 6 months prior to enrollment

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Dose Escalation part of AUBE00 monotherapy with or without prophylactic management 		Patients will receive AUBE00 as an oral administration at escalated doses. Patients may also receive prophylactic management for treatment-related adverse events.
  • Drug: AUBE00
    AUBE00 as an oral administration
Experimental
Part B: Expansion part of AUBE00 monotherapy 		Patients will receive AUBE00 as an oral administration at multiple dose levels determined to be safe (including MTD).
  • Drug: AUBE00
    AUBE00 as an oral administration
Experimental
Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab 		Patients will receive AUBE00 as an oral administration in combination with cetuximab as an IV infusion at escalated doses or the recommended dose level.
  • Drug: AUBE00
    AUBE00 as an oral administration
  • Drug: Cetuximab
    Cetuximab as an IV infusion

Recruiting Locations

South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan 49546

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Chugai Pharmaceutical

Study Contact

Clinical trials information
only use Email
clinical-trials@chugai-pharm.co.jp