169 Participants Needed

SNS-101 + Cemiplimab for Cancer

Recruiting in Pittsburgh (>99 mi)
+9 other locations
JL
JM
Overseen ByJanine McDermott
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

RW

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

My cancer is advanced, cannot be surgically removed, or has spread.
My cancer can be measured by tests.
Life expectancy of ≥ 3 months
See 5 more

Exclusion Criteria

I haven't had treatment for another cancer within the last 2 years, except for early-stage cancer treated with the aim of cure.
I experienced severe side effects from previous immunotherapy.
I haven't used specific therapies in the last 2 weeks.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Monotherapy Dose Escalation and Dose Expansion

SNS-101 is administered alone every 21 days to determine safety, tolerability, and optimal dosing

Approximately 15 months
Every 21 days

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

Approximately 15 months
Every 21 days

Phase 2 Cohort Expansion

SNS-101 is administered alone or in combination with cemiplimab to evaluate efficacy in specific tumor types

Approximately 1 year
Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after the last dose

Treatment Details

Interventions

  • Cemiplimab
  • SNS-101
Trial OverviewThe study tests SNS-101 (an anti-VISTA antibody) alone or with Cemiplimab in patients with various advanced cancers. It aims to assess the safety and effectiveness of these therapies while monitoring how the body processes them.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimabExperimental Treatment2 Interventions
SNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D.
Group II: Part B - SNS-101 in combination with cemiplimab and Dose ExpansionExperimental Treatment2 Interventions
SNS-101 IV and cemiplimab IV every 21 days. Patients will initially enroll in dose escalation cohorts.
Group III: Part A - SNS-101 Monotherapy Dose Escalation and Dose ExpansionExperimental Treatment1 Intervention
SNS-101 IV alone every 21 days. Patients will initially enroll in dose escalation cohorts.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺
Approved in European Union as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇺🇸
Approved in United States as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Basal cell carcinoma (BCC)
  • Non-small cell lung cancer (NSCLC)
🇨🇦
Approved in Canada as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇧🇷
Approved in Brazil as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sensei Biotherapeutics, Inc.

Lead Sponsor

Trials
4
Recruited
210+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.
This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.
Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations.Ahn, J., Nagasaka, M.[2023]
Cemiplimab-rwlc (Libtayo) is an FDA-approved immunotherapy for advanced cutaneous squamous cell carcinoma (CSCC) that works by blocking the PD-1 receptor, enhancing the immune system's ability to fight tumors.
Clinical trials have shown that cemiplimab is effective in treating CSCC, although common side effects and safety issues were noted, highlighting the need for ongoing research to improve treatment outcomes and reduce toxicity.
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma.Ahmed, SR., Petersen, E., Patel, R., et al.[2019]
Cemiplimab is a PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which is crucial for enhancing the immune response against cancer cells.
In September 2018, cemiplimab received FDA approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation, marking a significant advancement in cancer treatment options.
Cemiplimab: First Global Approval.Markham, A., Duggan, S.[2023]

References

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]
Cemiplimab: First Global Approval. [2023]
Comparative efficacy of cemiplimab versus other systemic treatments for advanced cutaneous squamous cell carcinoma. [2021]
First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial. [2023]
Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]
Phase I/II Trial of Immunotherapy With Durvalumab and Tremelimumab With Continuous or Intermittent MEK Inhibitor Selumetinib in NSCLC: Early Trial Report. [2021]
Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). [2022]
Cetuximab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial. [2022]
Synergistic antitumor activity of TRAIL combined with chemotherapeutic agents in A549 cell lines in vitro and in vivo. [2006]
[Two cases with recurrent non-small cell lung cancer successfully treated with cisplatin and S-1]. [2016]