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RECRUITING 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

NCT06303505 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 250 participants
Start Date 2024-06-12
Est. Completion 2027-12
Phase Phase 1

Sponsor

Tubulis

33 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06303505

The ClinicalTrials.gov registry entry for NCT06303505 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tubulis, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention — of which TUB-040 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06303505 reports 15 study locations spanning 7 distinct geographic areas — top geographies include Other, Ohio, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Ovarian Cancer, Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06303505?

The interventions under investigation include: TUB-040 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06303505?

This trial is sponsored by Tubulis, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial