Dr Gonzalez-Martin on the Safety of TUB-040 in Ovarian Cancer

“We have determined the maximum tolerated dose [of TUB-040] to be 4.4 mg/kg. Focusing on the dose range of 1.67 mg/kg to 3.3 mg/kg, we can say that this ADC is safe and has a manageable toxicity profile.”

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, discussed safety data from the phase 1/2a NAPISTAR1-01 trial (NCT06303505) of the novel antibody-drug conjugate TUB-040 in patients with platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Safety data from NAPISTAR1-01 presented during the 2025 ESMO Congress indicated that the maximum tolerated dose of TUB-040 was 4.4 mg/kg, said Gonzalez-Martin. Focusing on patients who received the agent at 1.67 mg/kg to 3.3 mg/kg (n = 46), the antibody-drug conjugate was safe and has a manageable toxicity profile, he noted. Although 20% of patients treated at this dose range had dose reductions, no patients discontinued therapy due to a treatment-emergent adverse effect (TEAE), he added.

Grade 3 or higher TEAEs were observed in 35% of patients treated at the 1.67-mg/kg to 3.3-mg/kg doses, Gonzalez-Martin said. Most TEAEs were grade 1 or 2 in severity, he added. Common any-grade TEAEs included nausea (78%), fatigue (48%), neutropenia (41%), anemia (35%), and thrombocytopenia (13%). These TEAEs were reported at grade 3 or higher severity at respective rates of 4%, 0%, 22%, 9%, and 4%.

Only 2 cases of grade 1 pneumonitis were reported among patients treated at the 1.67-mg/kg to 3.3-mg/kg dose range, Gonzalez-Martin said. Treatment was able to be continued in these patients, he added. No significant ocular toxicities, stomatitis, bleeding, or neuropathy occurred, he concluded.

Disclosures: Gonzalez-Martin reported receiving research grants from GSK, Roche, ISCiii, and AECC; having advisor roles with Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, HederaDx, AbbVie/Immunogen, Incyte, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Regeneron, Roche, SOTIO, SUTRO, Seagen, Takeda, Tubulis, and Zalia; providing expert testimony for AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche, Takeda, Seagen, and ZaiLab; being the chairman of GEICO; and receiving travel support from AstraZeneca/MSD and GSK.