CytoDyn has submitted a Phase II basket trial protocol to the US Food and Drug Administration (FDA) seeking to assess leronlimab for the treatment of solid tumours.
Leronlimab is an investigational humanised IgG4 monoclonal antibody designed to inhibit the C-C chemokine receptor type 5 (CCR5) receptor, which is associated with tumour metastases.
Under a basket trial, one drug or combination is evaluated in various cancer populations. Enrolment is based on disease stage, histology, previous therapies, biomarkers, or demographic characteristics.
Commonly, the trial is a single-arm, activity-estimating study that will assess the overall response rate as the primary endpoint.
CytoDyn’s Phase II basket trial will involve 30 patients with CCR5+ locally advanced or metastatic solid tumours. It will investigate a 350mg, subcutaneous weekly dose of leronlimab.
The company plans to enrol patients with 22 different solid tumours, including glioblastoma, melanoma, lung, breast, ovarian, pancreas and bladder cancers.
CytoDyn president and CEO Nader Pourhassan said: “If leronlimab proves to be as effective in this basket trial as we have seen in the first four patients in our metastatic breast cancer (MBC) trials, we believe we will be able to file for another breakthrough therapy designation for the multiple cancer indications evaluated in this basket trial, which could cover approximately 22 different forms of cancers.”
Leronlimab holds US Food and Drug Administration (FDA) fast-track designation as a combination treatment with HAART for HIV patients and for metastatic triple-negative breast cancer patients.
Earlier this month, CytoDyn reported data from its studies of leronlimab in metastatic triple-negative breast cancer (mTNBC) and MBC.
The company is also conducting a Phase II trial to assess leronlimab for the treatment of graft versus host disease (GvHD).