NAPISTAR 1-01

A First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)

Open
Grade
High grade
Prior lines
1, 2, 3, 4, >4
Histology
Serous
Platin
Platinum resistant
Secondary platinum refractory
Phase
I
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.


Treatment duration

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

Eligibility

Main inclusion criteria:

  • No more standard of care treatment (SoC) options
  • 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 which can also be found on clinicaltrials.gov (NCT06303505). 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