Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer with a high unmet medical need. These treatments have potential for Orphan Drug Designation, which are diseases affecting less than 200,000 people in the United States (Read more).

Clinical Trials

Before a new treatment is available to the public, a series of clinical trials strictly regulated by a governing body such as the FDA in the United States must be performed to evaluate the safety and effectiveness of an investigational drug.

Current Qualigen Clinical Trials

In October 2023, Qualigen initiated a new study in the United States. This is a multi-site study, entitled “A Phase I, Multicenter, Open-label, Dose-Escalation and Dose Expansion, Safety, Pharmacodynamic and Pharmacokinetic Study of Intravenous QN-302 in Patients with Advanced or Metastatic Solid Tumors.”

Up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study. The exact number of patients to be enrolled will depend on the observed safety profile. The dose expansion (Phase 1b) cohort will enroll up to an additional 20 patients with advanced, metastatic solid tumors. The expansion cohort will further evaluate safety and assess for antitumor effect of QN-302.

The primary objectives of this Phase 1a study are:

  • To determine the MTD and the dose-limiting toxicities (DLTs) of QN-302 monotherapy in patients with advanced or metastatic solid tumors that have not responded to or have recurred following treatment with available therapies.
  • To establish the dose of QN-302 recommended for future studies (the Recommended Phase 2 Dose [RP2D]).

Learn more about these ongoing studies by visiting ClinicalTrials.gov.

ClinicalTrials.gov Identifier: NCT06086522

Policy on Expanded Access

Qualigen recognizes that some patients may be ineligible or otherwise unable to participate in a clinical trial. Qualigen also understands that when enrollment into a clinical trial is not an option, and where all currently available treatment options have been exhausted, some companies have established policies that may permit an investigational drug to be provided prior to regulatory approval or commercial availability.  These policies are commonly referred to as “expanded access” (or “compassionate use”) programs.  Under these programs, expanded access for an investigational drug may be appropriate when all of the following apply:  (1) a patient has a serious disease or condition, or a patient’s life is immediately threatened by their disease or condition; (2) there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; (3) patient enrollment in a clinical trial is not possible; (4) there are sufficient clinical data available with respect to both the investigational drug and the disease condition to anticipate that any potential benefits from treatment are likely to outweigh any potential risks to the patient; and (4) providing the investigational drug does not impede or compromise the clinical development or regulatory approval of the drug under investigation.

Generally, Qualigen does not provide investigational drugs to patients until there is sufficient data on the safety and efficacy of our products to allow patients and physicians to assess the risks and benefits of using these investigational drugs outside of a clinical trial context. Therefore, after careful consideration, Qualigen is not currently offering expanded access to any investigational drugs.  Qualigen believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. 

As Qualigen continues to gather clinical data on the safety and effectiveness of investigational drugs, this policy on Expanded Access may be re-assessed and updated.

For more information about Qualigen’s ongoing clinical trials, please visit our QN-302 clinical trial website on ClinicalTrials.gov or contact us via email at [email protected]. Please do not include any personal identifying information if submitting inquiries to [email protected].