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February 28, 2020updated 12 Jul 2022 11:57am

MapKure, BeiGene, and SpringWorks launch Phase I cancer study

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.

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.

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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.”

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.

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