US-based biopharmaceutical firm Aveo Oncology’s oral drug candidate tivozanib has advanced into the Phase II part of the Phase I/II TiNivo clinical trial to treat advanced renal cell carcinoma (RCC).
The Phase I/II trial is evaluating tivozanib in combination with Bristol-Myers Squibb’s Opdivo (nivolumab).
Tivozanib is a once-daily, potent, selective vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), while nivolumab is an anti-PD-1 therapy.
Tivozanib is currently being developed to optimise VEGF blockade, reduce off-target toxicities, improve efficacy and minimal dose modifications and also inhibits all three VEGF receptors.
Expected to recruit around 20 subjects, the Phase II part of the trial is reported to follow the successful completion of Phase I dose escalation part.
The Phase I portion evaluated two escalating dose cohorts of tivozanib combined with 240mg nivolumab every two weeks.
The combination was found to be well-tolerated to the full dose of tivozanib with no dose limiting toxicities.
From the Phase I part, the recommended Phase II dose (RP2D) was determined as a full dose tivozanib regimen of 1.5mg daily for a period of 21 days, followed by a seven-day rest period.
Aveo Oncology president and CEO Michael Bailey said: “As our registration strategy for single agent tivozanib reaches key inflection points, with a European regulatory decision expected in the near-term and readout of our US registration-directed TIVO-3 study expected in the first quarter of 2018, our attention is increasing on tivozanib immuno-oncology combinations that have the potential to deliver significantly improved outcomes and tolerability to patients.”