FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Public ClinicalTrials.gov record NCT06303505. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06303505
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2024
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
- Last update posted
- Sep 10, 2026
2024 – 2027
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama | Birmingham | Alabama | 35294 | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06510 | Not yet recruiting |
| Emory University | Atlanta | Georgia | 30322 | Not yet recruiting |
| Norton Cancer Institute Research | Louisville | Kentucky | 40217 | Not yet recruiting |
| Tufts | Boston | Massachusetts | 02111 | Not yet recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Not yet recruiting |
| START New Jersey East Brunswick | East Brunswick | New Jersey | 08816 | Recruiting |
| Mount Sinai | New York | New York | 10011 | Recruiting |
| Christ Hospital | Cincinnati | Ohio | 45219 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210# | Recruiting |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Asante / Heimann Cancer Center | Medford | Oregon | 97504 | Not yet recruiting |
| Allegheny Singer | Pittsburgh | Pennsylvania | 15212 | Not yet recruiting |
| Spartanburg Regional | Spartanburg | South Carolina | 29303 | Not yet recruiting |
| Start Dfw | Fort Worth | Texas | 76104 | Recruiting |
| Next Oncology Dallas | Irving | Texas | 75039 | Recruiting |
| START Mountain Region | West Valley City | Utah | 84119 | Recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Not yet recruiting |
| Next Oncology Virginia | Fairfax | Virginia | 22031 | Recruiting |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06303505, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06303505 live on ClinicalTrials.gov.