Checkpoint Therapeutics has commenced the dose expansion portion of its Phase I trial analysing the safety and tolerability of ascending doses of CK-301 in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers.
The trial will evaluate the fixed CK-301 dose of 800mg, the highest amount tested in dose escalation. This will be given every two weeks in up to 40 checkpoint therapy-naïve patients with select tumour types associated with high clinical response rates to anti-PD-1/L1 monotherapies.
It seeks to enrol first-line non-small cell lung cancer patients whose tumours have high PD-L1 expression.
The dose expansion study follows the successful completion of the dose escalation portion of the first-in-human, open-label, multi-centre trial.
The trial is currently enroling patients at various sites across Australia, New Zealand and Thailand.
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By GlobalDataIts secondary endpoints feature the evaluation or characterisation of the pharmacokinetics, immunogenicity and preliminary efficacy of CK-301.
After the dose escalation phase, up to four dose expansion cohorts may be enrolled in the study to further characterise the safety and efficacy of CK-301 in specific patient subgroups.
Checkpoint Therapeutics president and CEO James Oliviero said: “The completion of the dose escalation portion of our Phase I trial marks an important milestone in the clinical development of our anti-PD-L1 antibody, CK-301.
“Our focus now shifts to generating efficacy data in the dose expansion portion of the trial through the enrolment of patients with tumour types believed to have a high potential for objective response to anti-PD-L1 monotherapy.”
Checkpoint plans to report initial data from the new expansion cohort in the second half of this year, and aims to begin the first registration trial of CK-301 for the treatment of first-line non-small cell lung cancer by the first quarter of next year.
