Diakonos Oncology has dosed the first patients in its Phase I/II DOC-RM clinical trial of DOC1021 (dubodencel) for refractory melanoma.
The patients were dosed at City of Hope in California and the University of Alabama at Birmingham (UAB) in the US.
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The multicentre trial will assess the safety, immune activity, and preliminary clinical efficacy of DOC1021 in patients with unresectable or metastatic melanoma who have not responded to prior therapies, including anti-programmed cell death protein 1 (PD-1) treatment.
Patients in the study receive two courses of DOC1021 with pegylated interferon, with an optional booster dose at approximately six months.
Key endpoints include safety, objective response, levels of circulating tumour deoxyribonucleic acid (DNA), and analysis of immune biomarkers in tumour tissue and peripheral blood.
The first patients treated in the trial have not experienced significant acute adverse events, a result said to be consistent with the company’s previous clinical work in glioblastoma and pancreatic cancer.
Diakonos Oncology president and chief operating officer Jay Hartenbach said: “Roughly half of melanoma patients progress after checkpoint inhibition, and the options that follow are defined as much by their toxicity and cost as by their benefit.
“We are encouraged that the first patients have received DOC1021 treatment with no significant acute adverse events, consistent with our glioblastoma and pancreatic trials. We look forward to reporting initial preliminary results from DOC-RM by the end of the year.”
The DOC-RM trial is currently open at the University of Alabama at Birmingham, City of Hope, Massachusetts General Hospital, UT Southwestern, Banner MD Anderson Cancer Center, HonorHealth Research Institute, University of North Carolina, and Atlantic Health.
The research is supported with funding from Diakonos Oncology and a grant from the Cancer Prevention and Research Institute of Texas.
In May 2026, DOC1021 received fast track designation from the US Food and Drug Administration for unresectable or metastatic cutaneous melanoma.
