Leap Therapeutics has signed a collaboration agreement with Merck and Pfizer to initiate a Phase I/II clinical trial to evaluate TRX518 in combination with avelumab and chemotherapy to treat patients with advanced solid tumours.

As part of the agreement, Leap will conduct the trial in advanced solid tumours including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.

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Patient enrolment for the trial is expected to begin in the first quarter of next year.

Leap Therapeutics Clinical Development vice-president said: “The combination of TRX518 with anti-PD-L1 immunotherapy and cyclophosphamide has a solid scientific rationale and we look to build upon our early clinical and preclinical data highlighting the potential benefits of such a combination.”

TRX518 is an investigational product candidate developed by Leap as a humanised glucocorticoid-induced TNFR family related gene (GITR) agonist monoclonal antibody to improve the immune system’s anti-tumour response.

It is currently being evaluated in two advanced solid tumour studies.

“TRX518 has demonstrated encouraging potential with early clinical activity in patients with advanced solid tumours.”

Pfizer Global Product Development senior vice-president and Immuno-oncology, Early Development and Translational Oncology head Chris Boshoff said: “TRX518 has demonstrated encouraging potential with early clinical activity in patients with advanced solid tumours.

“This collaboration with Leap Therapeutics to evaluate TRX518 in combination with avelumab gives us the opportunity to investigate a potential novel immunotherapy treatment regimen as we pursue our mission of improving outcomes for patients living with hard-to-treat cancers.”

Avelumabs is a human anti-programmed death ligand-1 (PD-L1) antibody that has previously received accelerated approval from the US Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC). It previously also treated patients with locally advanced or metastatic urothelial carcinoma (mUC).

It is currently under further clinical evaluation for use in a range of tumour types under a global strategic alliance between Merck and Pfizer.