The US Food and Drug Administration (FDA) has granted clearance to Qualigen Therapeutics’ investigational new drug (IND) for initiating a Phase I clinical trial of QN-302 to treat advanced or metastatic solid tumours.

The initiation and enrolment of patients in the study is anticipated in the second half of this year while the dosing of patients is expected to be completed next year.

Qualigens’s multicentre, open-label, pharmacodynamic, pharmacokinetic, dose escalation and expansion study is designed to assess the safety, tolerability, and antitumour activity of the small molecule G-Quadruplex (G4)-selective transcription inhibitor QN-302.

A minimum of 24 patients with advanced or metastatic solid tumours who have not responded to or have recurred following treatment with standard therapies are selected for the trial.

Qualigen chairman and CEO Michael Poirier said: “This is a pivotal milestone for our therapeutics pipeline as it transitions us into a clinical-stage company.

“The IND clearance for QN-302 brings us closer to our objective of developing best-in-class treatments that can potentially provide new therapeutic options for patients with advanced or metastatic solid tumours.”

The company received the proceeds for this study through the divestiture of its diagnostics business in July.

It also received FDA’s orphan drug designation for QN-302 in January for treating pancreatic cancer. QN-302 is also used for treating prostate cancer, sarcomas, and others.

By inhibiting transcription of G4-containing cancer genes, QN-302 stabilises G4 complexes prevalent in the promoter region of oncogenes in many tumour types.