Malignant ovarian tumours with induced expression of carbonyl reductase show spontaneous regression. Credit: Libertas Academica.

Aravive has commenced the Phase Ib portion of a clinical trial evaluating the combination of AVB-S6-500 with standard-of-care to treat patients with platinum-resistant recurrent ovarian cancer.

The Phase Ib portion of the trial is an open-label study that aims to include platinum-resistant recurrent ovarian cancer patients.

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It seeks to determine the dose based on results from AVB-S6-500 trial that included healthy participants.

The primary endpoint of the portion is safety and pharmacokinetic / pharmacodynamic measurements.

Secondary endpoints comprise preliminary activity measures.

It will also evaluate the effects of AVB-S6-500 on biomarkers such as GAS6-AXL in serum and tumour tissues.

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“We anticipate the measurement of circulating free GAS6 will be highly useful as a biomarker of drug activity in this new trial.”

Aravive Research and Development (R&D) senior vice-president Gail McIntyre said: “Our initial Phase I clinical trial of this agent in healthy volunteers showed a favourable safety and tolerability profile, with no reported serious adverse events and no adverse events that limited dosing in the trial.

“We also suppressed circulating free GAS6 across all dose levels and higher doses suppressed circulating free GAS6 for a longer duration than lower doses.

“We anticipate the measurement of circulating free GAS6 will be highly useful as a biomarker of drug activity in this new trial. A reduction in this biomarker has correlated to anti-tumour activity in preclinical studies.”

Aravive further noted that increased levels of GAS6 have been associated with poor diagnosis in cancer.

Acting as a decoy molecule, AVB-S6-500 has the ability to neutralise GAS6 activity by binding to that molecule.

AVB-S6-500 is a new, high-affinity, soluble Fc-fusion protein developed to block the activation of GAS6-AXL signalling pathway.