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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

Study Summary

This trial tests a new antibody drug to treat advanced solid tumors, to see if it is safe and effective.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 until the MTD/RP2D is determined. Patients will receive the MTD/RP2D for dose expansion.

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 until the MTD/RP2D is determined. Patients will receive the MTD/RP2D for dose expansion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sensei Biotherapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

37 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

624 Previous Clinical Trials

381,495 Total Patients Enrolled

Ron WeitzmanStudy DirectorSensei Biotherapeutics, Inc.

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05864144 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion, Part B - SNS-101 in combination with cemiplimab and Dose Expansion, Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab

Non-Small Cell Lung Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05864144 — Phase 1 & 2

Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05864144 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enroll in this medical research project at the present time?

"Affirmative. According to clinicaltrials.gov, this medical experiment has been open for recruitment since June 1st 2023 and was recently revised on May 18th of the same year. The research is requiring 129 patients across two sites."

Answered by AI

How many participants are currently participating in this experiment?

"Affirmative. Documentation listed on clinicaltrials.gov confirms that the study, which was announced in June of 2023, is currently actively recruiting participants from two sites with a target enrollment of 129 individuals."

Answered by AI

What is the overarching aim of this medical experiment?

"According to Sensei Biotherapeutics, Inc., the primary outcome that will be evaluated over the span of a year is Adverse Events - Part A & B. In addition, further investigations into secondary outcomes such as Adverse Events - Part C (incidence and severity of any adverse reactions), SNS-101's pharmacokinetics in terms of maximum concentration and serum terminal half life are planned."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

2023. "A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05864144.

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