FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

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

Trial Details

NCT ID
NCT06303505
Phase
PHASE1 / PHASE2
Sponsor
Tubulis GmbH
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • TUB-040
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • New York, New York, United States|40.71427,-74.00597
  • Cincinnati, Ohio, United States|39.12711,-84.51439
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Oklahoma City, Oklahoma, United States|35.46756,-97.51643

Key Eligibility Criteria

  • Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
  • Disease not amenable to curative intent treatment.
  • Patients have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit b…
  • Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irra…

For full eligibility, visit ClinicalTrials.gov.

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