The agreement covers the execution of a Phase II clinical trial to assess the combination therapy for CDK4/6i resistant HR+, HER2- metastatic breast cancer. Credit: National Cancer Institute on Unsplash.

Carrick Therapeutics has announced a clinical trial partnership and supply agreement with The Menarini Group for evaluating the combination of samuraciclib and elacestrant in breast cancer patients.

The agreement between the companies covers the execution of a Phase II clinical trial to assess the new combination of Carrick’s samuraciclib (CT7001) and Menarini’s elacestrant to treat CDK4/6i resistant HR+, HER2- metastatic breast cancer patients.

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Samuraciclib is an oral and first-in-class inhibitor of CDK7, and Menarini‘s elacestrant is an oral selective estrogen receptor degrader (SERD).

The clinical trial will be jointly sponsored by Carrick and Menarini.

Carrick Therapeutics CEO Tim Pearson said: “We are excited to initiate this collaboration with Menarini to explore the potential of samuraciclib in combination with elacestrant for the treatment of advanced breast cancer.

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“Our pre-clinical work and prior clinical studies have validated the biology for SERD combinations with CDK7, pointing to potential synergies when combining samuraciclib with Menarini’s oral SERD, elacestrant.

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“This collaboration represents a shared commitment to maximising the potential of novel combination therapies to improve outcomes for people living with breast cancer.”

Carrick expects to commence the Phase II trial next year.

It will expand the company’s portfolio of clinical trials that are underway with samuraciclib.

Samuraciclib, which showed a favourable safety profile and encouraging efficacy in early clinical trials, is currently being assessed in prostate cancer.

The US Food and Drug Administration (FDA) granted Fast Track designations for the therapy for use in combination with fulvestrant to treat CDK4/6i resistant HR+, HER2- advanced breast cancer.