SNS-101 + Cemiplimab for Cancer
Trial Summary
What is the purpose of this trial?
This trial tests a new antibody treatment called SNS-101, alone or with another drug, in patients with advanced cancers. It aims to help the immune system attack cancer cells by blocking a protein that hides them.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as anti-PD-1/PD-L1 therapies, chemotherapy, or other investigational drugs, at least 2 weeks before starting the study. It's best to discuss your specific medications with the trial team to see if they need to be paused.
What data supports the effectiveness of the drug SNS-101 + Cemiplimab for cancer?
Cemiplimab has shown effectiveness in treating advanced cutaneous squamous cell carcinoma and non-small cell lung cancer by improving survival rates and enhancing the immune system's response to tumors. It has been approved for use in these cancers, indicating its potential benefit in treating other types of cancer as well.12345
Is the combination of SNS-101 and Cemiplimab safe for humans?
Cemiplimab, also known as Libtayo, has been shown to have an acceptable safety profile in clinical trials for advanced cutaneous squamous cell carcinoma, with most side effects being manageable. It has been associated with low rates of treatment discontinuation and death, indicating it is generally safe for use in humans.12367
What makes the drug SNS-101 + Cemiplimab unique for cancer treatment?
SNS-101 combined with Cemiplimab is unique because it involves a novel combination of an investigational drug (SNS-101) with Cemiplimab, an existing immune checkpoint inhibitor that targets PD-1 (a protein that helps keep the immune system in check). This combination aims to enhance the immune system's ability to fight cancer, potentially offering a new approach for patients who may not respond to standard treatments.89101112
Research Team
Ron Weitzman, MD
Principal Investigator
Sensei Biotherapeutics, Inc.
Eligibility Criteria
This trial is for adults with advanced solid tumors who've tried standard treatments without success or can't receive them. They must have measurable disease, good organ function, and a life expectancy of at least 3 months. Women and men able to have children must use effective birth control. People can't join if they've had certain recent cancer treatments, severe reactions to similar drugs, brain metastases, or are pregnant/breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Monotherapy Dose Escalation and Dose Expansion
SNS-101 is administered alone every 21 days to determine safety, tolerability, and optimal dosing
Phase 1 Combination Dose Escalation and Dose Expansion
SNS-101 is administered in combination with cemiplimab every 21 days to determine safety, tolerability, and optimal dosing
Phase 2 Cohort Expansion
SNS-101 is administered alone or in combination with cemiplimab to evaluate efficacy in specific tumor types
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cemiplimab
- SNS-101
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sensei Biotherapeutics, Inc.
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School