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) (NAPISTAR1-01)

NCT06303505 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Tubulis GmbH
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	250
Start date	2024-06-12
Completion	2027-12

Conditions

• Ovarian Cancer
• Non-small Cell Lung Cancer

Interventions

• TUB-040

Primary outcomes

• Determination of MTD — From enrollment until 30 days after last study drug
  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

Countries

United States, Belgium, Germany, Romania, Spain, Ukraine, United Kingdom