Clinical Trials

Expanded Access Policy

SELLAS Life Sciences is committed to developing promising new therapies to address the unmet medical needs of patients suffering from a broad range of cancers. Consistent with SELLAS’ mission to bring innovative therapies to patients diagnosed with cancer, our goal is to provide access to our therapeutics at the appropriate time and in a manner that is most beneficial to the relevant patient population. We are focused on enrolling patients in our ongoing clinical trials necessary to gain regulatory approvals and to make our therapies available broadly to patients as quickly as possible – this remains the primary way for patients to access our investigational drugs. We are privileged to collaborate with clinical investigators, study teams, and patients, who all participate in our clinical studies to develop new, safe, and effective therapies. We encourage all patients and physicians to visit the pipeline page of our website to learn more about SELLAS’ ongoing clinical trials and enrollment. Further information surrounding our clinical trials can also be found by searching ‘SELLAS’ or the name of the investigational drug on ClinicalTrials.gov.

Show more

We recognize that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in clinical trials, and thus, wish to access our investigational drugs. In these situations, SELLAS will consider requests from qualified physicians to use our investigational drugs, outside of the clinical trial setting i.e., in an Expanded Access Program (EAP), when certain conditions are met. These conditions are as follows:

  • The patient to be treated has a serious or immediately life-threatening illness and there is no satisfactory or comparable alternative therapy.
  • The patient is not eligible for, or cannot access, any ongoing clinical trials.
  • The potential benefit of the investigational drug to the patient outweighs the potential risk.  This should be evaluated by the patient’s physician and discussed in detail with the patient.
  • Expanded Access requests for our investigational drugs must come from a patient’s treating physician who agrees to comply with all applicable legal and regulatory requirements in relation to the request and any requirements in terms of medical criteria (e.g., clinical monitoring of the drug use), safety reporting or other data provision which SELLAS may require.
  • There is an adequate supply of the investigational drug, over and above what is required for the ongoing clinical trials and other patients on active treatment.
  • Providing the investigational drug will not interfere with clinical trials that could support a medical product’s development or marketing approval.

SELLAS is committed to providing a fair and equitable evaluation of all EA requests but will review requests on a case-by-case basis.  All requests must be submitted by the patient’s treating physician to .  SELLAS may require more detailed information in order to fully evaluate a request.  The fact that our investigational drug is made available to one patient does not guarantee it will be made available to future patients.  We do not guarantee that all requests for access will be granted, even when eligibility criteria are met.in order to fully evaluate a request. The fact that our investigational drug is made available to one patient does not guarantee it will be made available to future patients. We do not guarantee that all requests for access will be granted, even when eligibility criteria are met. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within five (5) business days after receipt. You can find further contact details on the contact page of our website.

At this time, we are only accepting Expanded Access requests for investigational galinpepimut-S (GPS). 

Show less

.elementor-accordion-icon {display:none!important;} .elementor-accordion-title span.text-node {display:block!important} .comp-collapse-expand-all p.added-to-list1, .show_more p.added-to-list1, .wpsm-hide p.added-to-list1, .collapse-expand-all p.added-to-list1{display:none!important;} .like-share-container{display:none!important;} .elementor-tab-title {font-weight:700!important} .wpsm-show, .wpsm-hide{display:none!important;} #pf-body ul li:first-child:last-child { list-style-type: disc!important; } #pf-body ul li::marker { list-style: none!important;unicode-bidi: none;} #pf-body ul li li , #pf-body ul li li:first-child:last-child{ list-style-type: circle!important; } #pf-body ul li li li{ list-style-type: square!important; } #pf-body h1, #pf-body h2, #pf-body h3, #pf-body h4 {border:none!important} .wpcf7-form {display:none!important;}