NAPISTAR 1-02

A multicenter, Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical activity of TUB-040, in combination with standard ovarian cancer drugs in patients with high-grade epithelial serous or endometroid epithelial ovarian cancer. (NAPISTAR 1-02)

Open
Grade
High grade
Prior lines
1, 2
Histology
Serous, Endometrioid
Platin
Platinum sensitive
Phase
I/II
IMP
TUB-040
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

  • TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b.
  • TUB-040 is given IV every 3 weeks, combined with carboplatin (max. 6 cycles) and bevacizumab

 

Treatment duration
 

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility
 

Main inclusion criteria:

  • Platinum-sensitive ovarian cancer (max. 2 prior lines)
  • Measurable disease by RECIST 1.1
  • Archival tissue available for determination of biomarker (eg. NaPi2b) expression

 

Main exclusion criteria:

  • Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.

 

Disclaimer: This is an overview of the main in- and exclusion criteria. Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact
 

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be