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NCT06303505 · ClinicalTrials.gov registry record · Phase 1
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by Tubulis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 15
- Study locations
NCT06303505: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by Tubulis.
NCT06303505 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is actively recruiting participants, run by Tubulis. The registered enrollment target is 250 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower). The trial reports 15 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06303505, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is actively recruiting participants, sponsored by Tubulis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 15
- Study locations
Study Summary
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 least two doses are compared with each other to determine which dose is optimal for patients. TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.
Primary Outcome
The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria
Conditions Studied
Interventions
- DRUG TUB-040
Study Locations (15)
Other
- UZ Leuven - Leuven
- Charité Universitätsmedizin Berlin - Berlin
- University Hospital Cologne Department of Internal Medicine I - Cologne
- Arensia Exploratory Medicine - Cluj-Napoca
- Clínica universidad de Navarra - Madrid
- NEXT Oncology Madrid - Madrid
- Arensia Exploratory Medicine - Kyiv
- Guy's Hospital - London
Ohio
- Christ Hospital - Cincinnati
- Ohio State University - Columbus
Alabama
- The University of Alabama - Birmingham
New York
- Mount Sinai - New York
Oklahoma
- OU Health Stephenson Cancer Center - Oklahoma City
Texas
- Next Oncology Dallas - Irving
Virginia
- Next Oncology Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-06-12 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT06303505 shows while recruiting
NCT06303505 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which TUB-040 is the first listed.
NCT06303505 lists 15 locations in 7 states (Other, Ohio, Alabama).
Frequently Asked Questions
What is clinical trial NCT06303505 about?
NCT06303505 is a clinical study titled "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 w...
What is the current status of trial NCT06303505?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2024-06-12. Estimated completion is 2027-12.
What conditions does trial NCT06303505 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer.
What interventions are being tested in trial NCT06303505?
The interventions under investigation include: TUB-040 (DRUG).
Who is sponsoring clinical trial NCT06303505?
This trial is sponsored by Tubulis, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06303505 being conducted?
This trial has 15 study locations across Alabama, New York, Ohio, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06303505's enrollment target sits among peer trials
250 144th of 454 higher than 309 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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