Avacta Group has opened the first two clinical investigator sites in the US for the Phase I clinical trial of AVA6000.
Under the US investigational new drug (IND) application, the company opened Fred Hutch Cancer Center in Seattle and Memorial Sloan Kettering Cancer Center (MSK) in New York for enrolment of participants in the trial.
The latest move marks a significant milestone in the company’s plan to expand clinical trials of its pre|CISION drug candidate, AVA6000.
The Phase I clinical trial is said to be the first-in-human trial of AVA6000 to treat soft tissue sarcoma.
Avacta stated that a Phase Ia dose escalation trial is now being conducted in the UK.
It recently started dosing participants in the fifth cohort at 250mg/m2, after AVA6000’s favourable safety profile is generated in the trial conducted to date.
Currently, enrolment of patients with soft tissue sarcoma commenced in the Phase I clinical trial in the US.
Initially, these US trial sites will provide participants for the dose escalation phase of the trial.
In the trial, participants will receive the same doses at each trial stage as in the UK.
Avacta Therapeutics chief development officer Neil Bell said: “This timely opening of these two key US sites, under the expert direction of Dr Tap and Professor Cranmer, is a major milestone in Avacta’s entry strategy into the US with our promising AVA6000 pre|CISION lead programme.
“We share with our US colleagues a clear vision to transform treatment outcomes for patients, and we look forward to working together as we continue to build the clinical evidence base for the safety and tolerability of AVA6000, in addition to the significant tumour-targeting potential of the pre|CISION platform.”