Rigel Pharmaceuticals has signed a partnership with CONNECT, the international network of paediatric cancer centres, to initiate a Phase II clinical trial of REZLIDHIA (olutasidenib) in newly diagnosed paediatric and young adult patients with high-grade glioma (HGG).
In the trial, REZLIDHIA will be given along with temozolomide as maintenance treatment to patients with HGG harbouring an isocitrate dehydrogenase-1 (IDH1) mutation.
Under the partnership, CONNECT will incorporate olutasidenib into TarGeT-D, its molecularly directed Phase II umbrella clinical trial for HGG.
The Rigel-sponsored segment of the trial will focus on the post-radiotherapy dosing of olutasidenib with temozolomide, and subsequent administration of olutasidenib single agent for maintenance.
In this trial arm, 60 subjects aged under 39 years with IDH1 mutation-positive HGG, including diffuse intrinsic pontine glioma (DIPG), will be enrolled.
The study is expected to commence subject enrolment in the first half of this year.
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Rigel has committed to offering up to $3m, as well as study material throughout the four-year partnership period.
Analysing progression-free survival is the primary goal of the olutasidenib arm.
The trial will also characterise the tolerability, safety, and pharmacokinetics of the treatment in the paediatric and young adult demographic.
It will also meet the post-marketing paediatric study obligation of Rigel linked to the Food and Drug Administration (FDA) approval of REZLIDHIA for treating relapsed or refractory (r/r) acute myeloid leukaemia (AML).
REZLIDHIA is presently approved by the FDA to treat adults with r/r AML having susceptible IDH1 mutation.
Rigel Pharmaceuticals president and CEO Raul Rodriguez said: “We believe olutasidenib has potential in a variety of cancers where mIDH1 plays an important role and we look forward to generating new data in this disease state, which has a high unmet need.
“This collaboration builds on our haematology-oncology pipeline expansion strategy and enables us to explore the potential of olutasidenib in a focused and efficient manner.”