FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients Wit
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 topo
| Condition(s) | Ovarian Cancer, Non-small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 effe |
| Who can participate | Inclusion Criteria (for all patients) 1. Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent. 2. Disease not amenable to curative intent treatment. 3. Patients have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial. 4. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated. 5. Eastern Cooperative Oncology Group (ECOG) 0-1. 6. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV. 7. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarke |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tubulis GmbH |
| Locations | Birmingham, Alabama, United States; New York, New York, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States; Oklahoma City, Oklahoma, United States; Irving, Texas, United States (+9 more sites) |
| Start date | 2024-06-12 |
| NCT ID | NCT06303505 |
| Official listing | https://clinicaltrials.gov/study/NCT06303505 |