The study is structured in two parts conducted at various investigator sites throughout the US. Credit: Freedomz / Shutterstock.

Nammi Therapeutics has commenced the first in-human Phase I trial of QXL138AM by dosing the first subject for treating advanced solid tumours and multiple myeloma.

The dosing was conducted at The START Center for Cancer Research in San Antonio, Texas.

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The Phase I multi-centre and open-label study is structured in two parts. It is anticipated to enrol around 100 subjects with advanced cluster of differentiation 138 (CD138)-expressing cancers.

It will be conducted at various investigator sites throughout the US.

Part A will focus on the safety and tolerability of escalating doses of QXL138AM, while also evaluating pharmacokinetics and immunogenicity.

In Part B, the study will expand to dose cohorts with two solid tumour indications and multiple myeloma. The primary endpoints will assess safety and tolerability, with secondary endpoints examining anti-tumour activity.

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Specific solid tumour indications for expansion in Part B are yet to be selected.

The decision will be influenced by factors such as CD138 expression prevalence, preclinical efficacy, clinical efficacy of approved Interferon alfa therapeutics, unmet medical needs, and insights from Part A of the trial.

A masked immunocytokine (MIC), QXL138AM delivers a masked interferon alpha (IFNα) to the CD138 protein on tumour cells.

Utilising Nammi’s technology, the interferon alpha 2 is masked and linked to a tumour-targeting antibody, which is activated on the tumour surface by proteases.

This activation could offer a broader therapeutic space, as Interferon alpha 2 is an effective anti-cancer agent but is associated with significant toxicity when administered systemically.

The START Center for Cancer Research associate director Dr Drew Rasco said: “We’re very excited to have dosed the first patient with QXL138AM here at START.

“We believe that there is significant potential with Nammi’s immunocytokine technology in the treatment of multiple cancer types, and we look forward to working with the Nammi team to develop this new therapy over the coming years.”

QXL138AM received orphan drug designation (ODD) for pancreatic cancer in 2022.

The therapy also received ODD from the US Food and Drug Administration (FDA) for multiple myeloma in the same year.