FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC (NCT06303505)
A 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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: The University of Alabama — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- The University of Alabama — Birmingham, Alabama
- Mount Sinai — New York, New York
- Christ Hospital — Cincinnati, Ohio
- Ohio State University — Columbus, Ohio
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma
- Next Oncology Dallas — Irving, Texas
- START Mountain Region — West Valley City, Utah
- Next Oncology Virginia — Fairfax, Virginia
- 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,
📞 Contact the Study Coordinator
Phone: + 49 175 800 5594
Email: ct-inquiries@tubulis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ovarian Cancer
- Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy — New York, New York
- Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer — Pittsburgh, Pennsylvania
- Trial on Radical Upfront Surgery in Advanced Ovarian Cancer — New York, New York
- Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) — Duarte, California
- Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) — Little Rock, Arkansas
- NeoVax With Nivolumab in Patients With Ovarian Cancer — Boston, Massachusetts
Explore by condition: All Ovarian Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.