Dr Gonzalez-Martin on the NAPISTAR1-01 Trial of TUB-040 in Ovarian Cancer

“The focus of our presentation was the dose range from 1.67 mg/kg to 3.3 mg/kg. We included patients with high-risk, high-grade platinum-resistant ovarian cancer who have received up to a maximum of 7 prior lines of therapy, including 5 platinum-[based] and 2 non-platinum–[based treatments]”

Antonio Gonzalez-Martin, MD, the head of the Department of Medical Oncology at Clinica Universidad de Navarra, the director of the Cancer Center Clinica Universidad de Navarra, and an associate professor of medicine at Francis, outlined the key design features of the phase 1/2a NAPISTAR1-01 trial (NCT06303505) of TUB-040 in patients with platinum-resistant ovarian cancer, findings from which he presented during the 2025 ESMO Congress.

NAPISTAR1-01 was a dose-escalation and -optimization study that examined the novel antibody-drug conjugate (ADC) TUB-040 in patients with histologically confirmed, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study evaluated TUB-040 at doses ranging from 0.5 mg/kg to 5.3 mg/kg, he added. The focus of the presentation given during ESMO were the 1.67-mg/kg to 3.3-mg/kg cohorts, he noted.

Eligible patients needed to have received a maximum of 5 platinum-based and 2 non-platinum based prior lines of therapy, Gonzalez-Martin said; patients also were required to not have been treated with a prior ADC containing a topoisomerase-I inhibitor payload. An ECOG performance status of 0 or 1 was also required.

The primary end point of the study was safety and tolerability, as well as determining the maximum tolerated dose, Gonzalez-Martin said. Secondary end points included overall response rate per RECIST 1.1 criteria, disease control rate, progression-free survival, and overall survival, he concluded.

Overall, 67 patients received TUB-040 at any dose level. The median exposure to the agent was 161 days (range, 21-462). The median number of prior lines of therapy was 4 (range, 1-7) and the median age was 62.0 years (range, 34.0-81.0).