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Brief Title: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Official Title: A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Study ID: NCT03573544
Brief Summary: The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Scripps Clinic Torrey Pines, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
West Cancer Center and Research Institute, Germantown, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Name: Apostolia Tsimberidou, MD, PHD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR