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.

“The completion of the dose escalation portion of our Phase I trial marks an important milestone in the clinical development of CK-301.”

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.

Its secondary endpoints feature the evaluation or characterisation of the pharmacokinetics, immunogenicity and preliminary efficacy of CK-301.

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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.