Tolero Pharmaceuticals has dosed the first patient in a Phase I trial assessing TP-1287 for the treatment of patients with advanced solid tumours.

The Phase l trial is currently taking place at sites in the US and intends to investigate the maximum tolerated dose and dose-limiting toxicities of TP-1287.

Tolero intends to enrol 60 patients as part of the open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamics trial.

Patients with advanced metastatic or progressive solid tumours who are refractory to, or intolerant of will be eligible for the trial.

“The initiation of this study is an important step forward in understanding the potential of TP-1287.”

The trial’s primary endpoints are to establish the maximum tolerated dose and dose-limiting toxicities of oral TP-1287, as well as determine the Recommended Phase II Dose (RP2D).

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Secondary endpoints comprise pharmacokinetics, antitumour activity, and pharmacodynamics of TP-1287.

The study is set to be completed in May 2021 and primary data is expected to be available by February 2021.

Tolero Pharmaceuticals CEO David Bearss said: “The initiation of this study is an important step forward in understanding the potential of TP-1287 in patients with solid tumours.

“We believe that the oral administration of TP-1287 may be beneficial in disease settings where this form of administration is preferred or when used in combination with other targeted agents.”

TP-1287 is an experimental oral cyclin-dependent kinase 9 (CDK9) inhibitor that showed positive oral bioavailability in preclinical models.