FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Sponsor: Gilead Sciences • ClinicalTrials.gov ID: NCT06303505
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The purpose of this multicenter, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in participants with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of three parts: In dose escalation, ovarian cancer participants and lung cancer participants receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for participants. In dose expansion, a single dose will be used in a larger number of participants. TUB-040 is given IV every 3 weeks until the disease progresses or the participants has to stop due to side effects.
Interventions
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TUB-040
(Drug)
A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Eligibility criteria
Conditions
Locations
- The University of Alabama — Birmingham, Alabama, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Emory University — Atlanta, Georgia, United States
- Norton Cancer Institute Research — Louisville, Kentucky, United States
- Tufts — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- START New Jersey East Brunswick — East Brunswick, New Jersey, United States
- Mount Sinai — New York, New York, United States
- Christ Hospital — Cincinnati, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- Asante / Heimann Cancer Center — Medford, Oregon, United States
- Allegheny Singer — Pittsburgh, Pennsylvania, United States
- Spartanburg Regional — Spartanburg, South Carolina, United States
- Start Dfw — Fort Worth, Texas, United States
- Next Oncology Dallas — Irving, Texas, United States
- START Mountain Region — West Valley City, Utah, United States
- Inova Schar Cancer Institute — Fairfax, Virginia, United States
- Next Oncology Virginia — Fairfax, Virginia, United States
- Providence Sacred Heart Medical Center — Spokane, Washington, United States
- UZ Leuven — Leuven, Belgium, Belgium
- Charité Universitätsmedizin Berlin — Berlin, Germany
- University Hospital Cologne Department of Internal Medicine I — Cologne, Germany
- Puerto Rico Cancer Clinical Trials — San Juan, Puerto Rico
- Arensia Exploratory Medicine — Cluj-Napoca, Romania
- Clínica universidad de Navarra — Madrid, Spain
- NEXT Oncology Madrid — Madrid, Spain
- Arensia Exploratory Medicine — Kyiv, Ukraine
- Guy's Hospital — London, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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