What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include monoclonal antibodies, immune checkpoint inhibitors, and chemotherapy. Monoclonal antibodies like anti-EGFR can cause acneiform rash, fatigue, diarrhea, and infusion-related reactions. Immune checkpoint inhibitors such as pembrolizumab and nivolumab are associated with immune-related toxicities, including pneumonitis, rash, pruritus, and diarrhea. Chemotherapy regimens, often combined with these agents, can lead to nausea, vomiting, fatigue, and myelosuppression. Specific to the SNS-101 trial, which involves an anti-VISTA IgG1 monoclonal antibody, potential side effects may include immune-related adverse events similar to other immune checkpoint inhibitors.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, an anti-PD-1 monoclonal antibody, has shown significant improvements in overall survival (OS) and progression-free survival (PFS) when combined with chemotherapy. Nivolumab, another anti-PD-1 antibody, has demonstrated improved OS and response rates compared to chemotherapy in patients with advanced NSCLC. Atezolizumab, an anti-PD-L1 antibody, is approved for patients with metastatic NSCLC who have progressed after platinum-based chemotherapy. Durvalumab, also an anti-PD-L1 antibody, is approved for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. These treatments highlight the role of immunotherapy in managing advanced NSCLC.

What other types of research exist?

Promising novel alternatives to SNS-101 for NSCLC patients include: 1) Bevacizumab, an anti-VEGF antibody, which has shown potential in preventing brain metastases in NSCLC. 2) Pembrolizumab, a PD-1 inhibitor, which has demonstrated clinical efficacy in advanced NSCLC, particularly in patients with PD-L1 expression. 3) Atezolizumab, another PD-L1 inhibitor, which has shown efficacy in combination with bevacizumab in renal cell carcinoma and may be considered for NSCLC. These therapies represent significant advancements in the treatment landscape for NSCLC.

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Monoclonal Antibodies

SNS-101 + Cemiplimab for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Sensei Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 15 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include allergic reactions due to antibodies, fatigue from immune system engagement, issues related to organ inflammation as an immune response, and possibly other common drug-related adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events - Part A & B

Determine the Recommended Phase 2 dose or maximum tolerated dose - Part A & B

Objective Response Rate (ORR) - Part C

Secondary study objectives

Adverse Events - Part C

Determine pharmacokinetic profile (area under the curve) of SNS-101 - Part A, B & C

Determine pharmacokinetic profile (maximum concentration) of SNS-101 - Part A, B & C

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and targeted therapy. Immunotherapy, such as anti-PD-1/PD-L1 antibodies, enhances the immune system's ability to attack cancer cells by blocking inhibitory signals that prevent T-cells from targeting tumors. Targeted therapies focus on specific genetic mutations within cancer cells, inhibiting their growth and survival. The SNS-101 trial explores an anti-VISTA IgG1 monoclonal antibody, which targets the VISTA protein to potentially boost anti-tumor immunity. These mechanisms are vital for NSCLC patients as they enable personalized treatment approaches, improving the likelihood of effective outcomes based on individual tumor profiles.