Diakonos Oncology has dosed the first patients in its Phase I/II DOC‑RM trial of DOC1021 (dubodencel) for refractory unresectable or metastatic melanoma, with initial treatments at City of Hope and UAB. The multicenter study will assess safety, immune activation, and early efficacy in patients who failed prior therapies, including anti–PD‑1 agents. Participants receive two courses of DOC1021 with pegylated interferon and an optional booster at about six months; early patients reported no significant acute adverse events. DOC1021 received FDA Fast Track designation in May 2026, and preliminary results are expected by year‑end.
Diakonos Begins Dosing in Phase I/II DOC‑RM Trial of DOC1021 for Refractory Melanoma — Fast Track Designation Secured
The trial will assess DOC1021 in unresectable or metastatic melanoma patients. Credit: Tapati Rinchumrus / Shutterstock.com.
Diakonos Oncology has dosed the first patients in its Phase I/II DOC‑RM clinical trial of DOC1021 (dubodencel) for refractory, unresectable or metastatic melanoma. Initial dosing took place at City of Hope in California and the University of Alabama at Birmingham (UAB).
Trial Design and Treatment
The multicenter study will evaluate the safety profile, immune activation, and preliminary clinical efficacy of DOC1021 in patients who have not responded to prior therapies, including anti–PD‑1 agents. Participants receive two courses of DOC1021 in combination with pegylated interferon, with an optional booster dose offered at approximately six months.
Endpoints and Early Safety
Primary and secondary endpoints include safety, objective response rates, measurements of circulating tumor DNA (ctDNA), and immune biomarker analyses in tumor tissue and peripheral blood. According to Diakonos, the first patients treated have not experienced significant acute adverse events, a finding consistent with the company’s earlier clinical work in glioblastoma and pancreatic cancer.
Jay Hartenbach, President and COO of Diakonos Oncology, 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."
Sites, Funding and Regulatory Status
The DOC‑RM trial is currently enrolling at multiple U.S. centers, including the University of Alabama at Birmingham, City of Hope, Massachusetts General Hospital, UT Southwestern, Banner MD Anderson Cancer Center, HonorHealth Research Institute, the University of North Carolina, and Atlantic Health. The research is funded by Diakonos Oncology and a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
In May 2026, DOC1021 received Fast Track designation from the U.S. Food and Drug Administration for unresectable or metastatic cutaneous melanoma, a regulatory status intended to expedite development for treatments addressing unmet medical needs. Diakonos plans to report initial preliminary results from DOC‑RM by the end of the year.
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