MBrace Therapeutics has commenced dosing in its Phase I/Ib clinal trial of antibody-drug conjugate (ADC), MBRC-101, in advanced metastatic solid tumour patients, with tumours refractory to standard therapy.

The multicentre, open-label, first-in-human, dose-escalation and dose-expansion trial will analyse MBRC-101 in these patients.

The Phase I dose escalation portion will enrol nearly 30 subjects to detect the optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of one or more dosing schedules of the ADC. 

The Phase Ib dose expansion will analyse the initial clinical activity and safety of MBRC-101 at selected OBRDs. 

These two phases will evaluate the single and multiple-dose pharmacokinetics profiles and analyse the occurrence and persistence of anti-MBRC-101 Ab.

Optimal biologically relevant doses, maximum tolerated dose, safety, and anti-tumour activity will be the primary goals of the trial. 

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To validate the ADC’s efficacy, the trial will also analyse the overall response rate, progression-free survival, response rate, overall survival, complete response, and partial response.

MBrace Therapeutics president and CEO Isan Chen said: “Developed using our proprietary SPARTA platform, MBRC-101 is our first drug candidate and has the potential to treat a variety of very commonly occurring cancers. 

“SPARTA is a robust antibody and target discovery platform which, by overcoming several limitations of previous approaches, accelerates translation into clinical applications. 

“The dosing of the first four patients in our first clinical trial marks an important milestone, as MBrace works to deliver new and effective ADCs to patients facing difficult-to-treat cancers.”

MBRC-101 was shown to have strong anti-tumour activity in various patient models of breast cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma in preclinical research. 

MBRC-101 acts on the EphA5 receptor tyrosine kinase, seen in various cancer types.

It is claimed to be the first candidate from the ADC pipeline of MBrace to enter the clinic.