Race Oncology doses first patient in phase 1b/2 AML trial of FluCloZan
Race Oncology has dosed the first patient in the phase 1b/2 trial of its Zantrene (bisantrene dihydrochloride) in combination with Fludarabine and Clofarabine (FluCloZan) in relapsed/refractory acute myeloid leukaemia (AML).
According to the Australian precision oncology company, the early-stage clinical trial will study the FluCloZan regimen as salvage therapy to be administered intravenously in adult patients.
The company said that the first patient in the AML clinical trial was dosed at the Chaim Sheba Medical Center in Israel. The phase 1b/2 trial will run parallelly with a separate Australian phase 2 trial in patients having extramedullary AML.
Dr David Fuller — Race Oncology CMO said: “We are delighted to see the start of this important clinical project which uses a novel combination approach for relapsed or refractory Acute Myleoid Leukaemia. This study is also an important step in our journey towards approval of Zantrene in this area of high unmet medical need.”
The phase 1b part of the clinical trial will have up to a dozen patients, while phase 2 will have up to 17 patients.
Race Oncology said that the phase 1b trial will be a dose escalation study in two cohorts. The first cohort will have three patients subjected to the FluCloZan regimen for four consecutive days. If the patients do not show any dose limiting toxicities (DLTs) by day 30 of their first cycle of treatment, then the second cohort 2 will get the treatment for five days, with the extra day representing dose escalation.
The phase 2 AML trial will be the efficacy study for the FluCloZan regimen. To begin with, nine patients will be roped in and subjected to the recommended phase 2 dose of the drug regimen as established in the phase 1b part of the study.
If the FluCloZan regimen does not evoke any responses in the first nine subjects, then the study will be ended for futility. In case of at least one patient showing a response, then eight more patients will be enrolled and subjected to the drug regimen.
Race Oncology said that if three or more of the patients treated with the drug regimen in stage 2 respond, then the null hypothesis of treatment futility can be rejected.
Phillip Lynch — Race Oncology CEO and MD said: “We hope to see improved patient outcomes in what has been historically a difficult to treat disease.
“We plan on using our trademarked name, Zantrene, in referring to bisantrene dihydrochloride. It’s one of our registered trademarks and its protection is enhanced by its ongoing and appropriate use.”