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

The goal of this clinical study is to learn more about the study drug, TUB-040, including its safety, tolerability, pharmacokinetics, and preliminary efficacy, and to determine the best dose of TUB-040 in participants with ovarian cancer or non-small cell lung cancer (NSCLC). The primary objectives of this study are: Phase 1: To determine the safety and tolerability of TUB-040 and determine the maximum tolerated dose (MTD) or the identified dose for optimization (IDO). Phase 2a: To assess safety of TUB-040, the preliminary efficacy of TUB-040, and to identify the recommended phase II dose (

Trial Details

NCT ID
NCT06303505
Phase
PHASE1 / PHASE2
Sponsor
Gilead Sciences
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • TUB-040
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • East Brunswick, New Jersey, United States|40.42788,-74.41598
  • New York, New York, United States|40.71427,-74.00597

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.
  • Individuals have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefi…
  • Individuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.

For full eligibility, visit ClinicalTrials.gov.

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