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Brief Title: A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
Official Title: A Phase 1 Open-label, Dose-escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT05012618
Brief Summary: This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18 when administered as a single agent or in combination with other anti-cancer drugs 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
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, United States
Renown Regional Medical Center, Reno, Nevada, United States
NEXT Oncology, Austin, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
NEXT Virginia, Fairfax, Virginia, United States
University of Wisconsin - Carbone Cancer Center, Madison, Wisconsin, United States
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan
Name: Sponsor Chugai Pharmaceutical Co. Ltd
Affiliation: clinical-trials@chugai-pharm.co.jp
Role: STUDY_DIRECTOR