RECRUITING

Study of AUBE00 in Patients With Solid Tumors

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Conditions

Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 70 to 100.

Official Title

A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors

Quick Facts

Study Start:2025-06-05
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07030959

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years at time of signing Informed Consent Form (ICF)
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. * Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part)
  4. * Refractory or resistant to standard therapies or standard therapies are not available
  1. * Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study or within 27 weeks after the last dose of AUBE00
  2. * 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)
  3. * 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
  4. * 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

Contacts and Locations

Study Contact

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

Principal Investigator

Sponsor Chugai Pharmaceutical Co.Ltd
STUDY_DIRECTOR
clinical-trials@chugai-pharm.co.jp

Study Locations (Sites)

South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Chugai Pharmaceutical

  • Sponsor Chugai Pharmaceutical Co.Ltd, STUDY_DIRECTOR, clinical-trials@chugai-pharm.co.jp

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-05
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2025-06-05
Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors