The trial will enrol adults with a variety of solid tumours. Credit: Penn State.

MapKure, BeiGene and SpringWorks Therapeutics have initiated a Phase I clinical trial of BGB-3245 for the treatment of advanced or refractory solid tumour patients in Australia.

The US Food and Drug Administration (FDA) has accepted an investigational new drug (IND) filing seeking approval to perform the trial in the US.

BGB-3245 is intended to block monomeric and dimeric forms of activating B-RAF mutations, which are linked to the development of some cancers.

MapKure scientific advisory board chair Neal Rosen said: “Preclinical data suggest that BGB-3245 could potentially address a range of B-RAF driven tumours, which represent a significant need for patients who currently lack targeted therapeutic options, as well as patients who have developed resistance to first-generation B-RAF inhibitors.

“If our hypothesis is correct, we believe that BGB-3245 could have meaningful, single-agent anti-tumour activity in B-RAF-altered cancers through its ability to address key primary and resistance gene alterations that are currently unaddressed by approved therapies.”

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The open-label, dose-escalation and expansion Phase I trial will assess the safety, pharmacokinetics (PK) and anti-tumour activity of the drug candidates in adults with solid tumours.

The dose and tolerability of BGB-3245 will be determined during the trial, along with early anti-tumour activity data to allow cohort expansion.

Patients who progressed during or after a minimum of one previous line of systemic anti-cancer therapy or are intolerable or ineligible will be enrolled into the trial.

The Phase Ia part of the study will involve dose-escalation and dose-finding evaluations to identify the maximum tolerated dose and/or the recommended Phase II dose. The part will also monitor the pharmacokinetics of BGB-3245 in patients with MAPK pathway aberrations.

The Phase Ib part will comprise one or more expansion cohorts to assess the pharmacokinetics, safety, and tolerability of BGB-3245 at the recommended Phase II dose.

In addition, the second part will track preliminary anti-tumour activity in patients with select tumour types and B-RAF status.