The purpose of this multicentric, 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 patients 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 two parts: In dose escalation, ovarian cancer patients and lung cancer patients 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 patients. TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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
Mount Sinai
New York, New York, United States
RECRUITINGChrist Hospital
Cincinnati, Ohio, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGOU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
RECRUITINGNext Oncology Dallas
Irving, Texas, United States
RECRUITINGNext Oncology Virginia
Fairfax, Virginia, United States
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGCharité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGUniversity Hospital Cologne Department of Internal Medicine I
Cologne, Germany
RECRUITINGArensia Exploratory Medicine
Cluj-Napoca, Romania
RECRUITING...and 4 more locations
Determination of MTD
The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria
Time frame: From enrollment until 30 days after last study drug
Maximum plasma/serum concentration (Cmax)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Time frame: From enrollment until 30 days after last study drug
Through plasma/serum concentration (Cmin)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmin will be derived).
Time frame: From enrollment until 30 days after last study drug
The time taken to reach the maximum concentration (Tmax)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Time frame: From enrollment until 30 days after last study drug
Area Under Curve (AUC)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (AUC will be derived).
Time frame: From enrollment until 30 days after last study drug
Half life (T1/2)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (T1/2 will be derived).
Time frame: From enrollment until 30 days after last study drug
Determination of immunogenicity
Number and percentage of patients developing anti-TUB-040 antibodies, and semiquantitative titer assessment. It is measured at cycles 1, 2, 3, 4, 6, 8, 10, post treatment
Time frame: From enrollment until 30 days after last study drug
Determination of efficacy
ORR by investigator assest Recist 1.1
Time frame: From enrollment until 30 days after last study drug
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