Galectin Therapeutics has dosed the first patient in a Phase 1/2 trial demonstrating the safety and efficacy of its carbohydrate-based galectin inhibitor compound, GM-CT-01, in combination with a Ludwig Institute peptide vaccine for treating advanced metastatic melanoma.
The trial is being conducted in collaboration with the Cancer Centre at the Cliniques universitaires Saint-Luc, Belgium, and the Ludwig Institute for Cancer Research (LICR), US.
The Phase 1/2 trial enrols patients who have metastatic melanoma with regional or distant metastatic disease with either HLA-A1 type and MAGE-3 or HLA-A2 type and NA17.A2 expressed by the tumour.
In the study, patients with at least one measurable lesion will be assigned to group 1 and will receive peptide vaccinations and systemic GM-CT-01 injections, while patients with at least one measurable and at least one superficial metastasis will be assigned to group 2 and will receive peptide vaccinations, systemic GM-CT-01 administrations and peritumoral administration of GM-CT-01.
Patients will receive a peptide vaccine injection at three-week intervals throughout the study and GM-CT-01 intravenously every three days, beginning after the third dose of the peptide vaccine.
The study's primary endpoints include safety and tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines and secondary endpoints will include overall survival and immunological measurements.
Cliniques universitaires Saint-Luc Cancer Center professor Jean-François Baurain said the first-in-human Phase 1/2 study combines active vaccination and immunomodulatory agents to improve the immune system's ability to kill cancerous cells.
"The initiation of this trial is an important step in evaluating a potential new treatment modality for patients with advanced metastatic melanoma, who experience limited success with currently available therapies," Baurain added.
Galectin Therapeutics CEO Peter Traber said: "Galectin Therapeutics is committed to realising the promise of galectin inhibition in cancer immunotherapy and this trial of vaccine plus galectin inhibitor in metastatic melanoma is a critical first step in that effort."
Image: Melanoma in skin biopsy with H&E stain. Photo courtesy of: KGH.