At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- TUB-040 (drug)
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- TUB-040 — drug: A complete treatment cycle is defined as 21 calendar days.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 250
- Started
- 2024-06-12
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for ovarian cancer
- • Phase1/Phase2 - 250 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ovarian cancer
Where?
- • London - Guy's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ or surgical procedures to ≤grade 1 (except alopecia
- ✓ steroids or has current ILD/pneumonitis
What the study is looking for
- ✓Key Inclusion Criteria (for all phases)
- ✓Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
- ✓Disease not amenable to curative intent treatment.
- ✓Participants have exhausted the the usual treatment treatment (SoC) with expected survival benefit and are not denied...
- ✓Participants with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
See the full criteria
Where Is This Study? (1 UK site)
Guy's Hospital
London SE1 9RT, United Kingdom
How to Get in Touch
Tubulis Clinical Trial Inquiries
Sponsor contactCONTACT
