SQ3370 clinical studies

Before any novel treatment can be used to treat patients, multiple studies need to be conducted to evaluate efficacy and safety. Shasqi has advanced SQ3370 to a phase 2 clinical study, designed to evaluate safety and tolerability, as well as the ability of SQ3370 to shrink tumors. The study is enrolling patients with soft tissue sarcoma and head and neck cancer. If you would like to find out more about our clinical trial, please contact us at: clinicalstudies@shasqi.com or find more information on our clinicaltrials.gov profile.

Policy on expanded access to investigational drugs

Shasqi is committed to providing safe, fair, and sustainable patient access to its investigational compounds at different stages of lifecycle development. Shasqi is currently planning and conducting clinical trials to assess the potential safety, tolerability, and efficacy of SQ3370, which is an investigational compound.

Expanded access and compassionate use programs allow patients to gain access to investigational compounds outside of a clinical trial. Under the 21st Century Cures Act, the manufacturer of a drug for a serious disease or condition may provide the drug to eligible patients under certain conditions.

In order to ensure appropriate access to SQ3370 and to safeguard the welfare of clinical trial subjects and potential patients, Shasqi first needs to confirm that SQ3370 is safe, tolerable, and effective through controlled clinical trials. We believe the best way to make SQ3370 available to patients is by enrolling and completing all of our clinical trials and pursuing a regulatory approval pathway, thus enabling the broader population to get access.

Shasqi is not making SQ3370 available on an expanded access basis at this time. Additional information on Shasqi clinical trials can be found at clinicaltrials.gov. Our expanded access guidelines will be continuously reassessed, and any updates will be provided on our website. Shasqi reserves the right to update or revise its expanded access policy at any time. For information on any updates or changes to Shasqi’s expanded access policy and current clinical studies, please visit clinicaltrials.gov or www.shasqi.com. Shasqi’s publication of this current policy or any future policy shall not serve as a guarantee of access to any specific investigational compound by any individual.

Currently, participation in clinical trials is the only way for patients to gain access to SQ3370. As more clinical data on the safety and efficacy of this investigational therapy becomes available, we will review and update our policy on Expanded Access.