Drug or vaccine development is the process of turning an idea for a potential medicine or vaccine into a treatment that can help patients. At Speratum Biopharma, this journey begins with laboratory research and preclinical studies (in vivo and in vitro trials). It continues through clinical trials with people, where we gather vital information about the safety and effectiveness of the medicine. This data is submitted to regulatory authorities, like the U.S. Food & Drug Administration (FDA), for approval before the medicine becomes available to patients.

Clinical trials are research studies in which people volunteer to participate to help us understand how potential medicines or treatments affect human health. At Speratum Biopharma, clinical trials are a crucial step in our mission to develop life-changing cancer therapies. These trials allow us to evaluate how well our mRNA and siRNA medicines work, as well as their safety.

Every clinical trial is guided by a protocol, a detailed plan that describes:

The purpose and length of the trial
Study medicines, procedures, and tests involved
Participant eligibility criteria
How side effects will be monitored and managed
The rules and schedule for the trial
As a participant, you’ll be informed of these details during the informed consent process before you decide whether to join. Some trials may include randomization or use a placebo, and this will also be explained to you.

Your study-related medical care will be provided by a dedicated study team, including the principal investigator (PI) — the healthcare professional responsible for the trial at your location — and other clinical team members.

You may continue seeing your regular medical doctor for non-study-related care. It’s important to inform the study team about your health conditions and treatments to ensure coordination with your overall medical care.

All clinical trials carry potential risks, but measures are in place to protect participants. At Speratum Biopharma, we follow strict ethical and scientific guidelines, such as Good Clinical Practice (GCP), to ensure participant safety. Our trials are also overseen by regulatory authorities, ethics committees, and independent monitoring boards to safeguard your rights and well-being.

Clinical trials have specific eligibility criteria based on factors like age, health condition, and medical history. At Speratum Biopharma, these criteria help us ensure that the study is safe and appropriate for each participant.

Participation is always voluntary, and the decision to join is entirely yours. We encourage you to sign up for SperatumConnect to stay informed about upcoming trials that might be right for you.

Speratum Biopharma covers the costs of study-related medicines and procedures. In most cases, we also reimburse participants for reasonable expenses like travel, parking, and meals.

Details about costs and reimbursements will be provided during the informed consent process. If you have any questions, our study team will be happy to assist you.

Compensation varies depending on the specific clinical trial. Some studies may offer compensation for your time and effort, as well as for any expenses related to participation. These details will be outlined in the informed consent document for the trial.

You can stay updated on our clinical trials by joining SperatumConnect, a notification service that alerts you to research opportunities that might be right for you.

Currently, we do not have any open clinical trials for healthy volunteers, but we are looking forward to launching our first-in-human trials as early as late 2025 or Q1 2026.

We aim to provide study-related communication in the language that participants are most comfortable with. If you require assistance in a specific language, including Spanish, please inform the study team during the pre-screening process or when contacting the study location.

Once a clinical trial has finished recruiting participants, its listing may no longer appear on our website. However, you can find detailed information about completed trials at ClinicalTrials.gov.

If we don’t currently have a trial that matches your needs, consider exploring other clinical trials through ClinicalTrials.gov. You can also join SperatumConnect to stay informed about future opportunities with Speratum Biopharma.

Each trial is unique, and preparation may involve medical screenings, lifestyle adjustments, or scheduling regular visits. Our study team will guide you through the process and provide detailed instructions.

Our primary focus is on developing treatments for cancer, including pancreatic, lung, breast, and prostate cancers. We are also exploring treatments for infectious diseases such as influenza, RSV, and COVID-19.

By joining a clinical trial, you contribute to the advancement of medicine. You may gain access to innovative treatments and receive care from a dedicated medical team while helping future generations of patients.

We are committed to protecting your personal information. All data collected during the study is handled in compliance with applicable privacy laws and used only for research purposes.