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

Study acronym: NAPISTAR1-01
StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary endpoints added 1 → 3 primary endpoints
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Record History

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  1. Primary endpoint(s) modified
    • Trial sites expanded: 18 → 29 locations
    • Site details revised at 6 of 29 sites
    v13
  2. Study sites: 18 to 29v12
  3. Primary endpoints: 1 to 3
    • Study sites: 16 to 18
    • Eligibility criteria shortened, about 56 words
    • Secondary endpoints: 7 to 18
    v11
  4. Study sites: 15 to 16v10
  5. Site details revised at 4 of 15 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Jan 2027 to Dec 2027
    • Enrollment target: 200 to 250
    • Study sites: 14 to 15
    • Study arms: 2 to 3
    v8
  2. Enrollment target: 100 to 200v7
  3. Study sites: 12 to 14v6
  4. Study sites: 10 to 12v5
  5. Study sites: 7 to 10v4
  6. Study sites: 3 to 7
    • Start date changed from estimate of May 2024 to Jun 12, 2024
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this multicenter, 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 participants 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 three parts: In dose escalation, ovarian cancer participants and lung cancer participants 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 participants. In dose expansion, a single dose will be used in a larger number of participants. TUB-040 is given IV every 3 weeks until the disease progresses or the participants has to stop due to side effects.
Trial Details
NCT Number NCT06303505
Lead Sponsor Gilead Sciences
Conditions
(from sponsor)		 Ovarian Cancer, Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov