Trials / Active Not Recruiting
Active Not RecruitingNCT05864144
A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- Sensei Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors.
Detailed description
This is a first-in-human, Phase 1/2 open-label, multi-center, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101, a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors. This study is being conducted in three parts: * Part A: Phase 1 Monotherapy Dose Escalation and Dose Expansion (SNS-101 alone) * Part B: Phase 1 Combination Dose Escalation and Dose Expansion (SNS-101 in combination with cemiplimab) * Part C: Phase 2 Cohort Expansion (SNS-101 alone or in combination with cemiplimab) Once the dose escalation portion is complete enrollment will expand to targeted tumor types: * Approximately 10 patients with colorectal cancer (CRC) will be enrolled in the Monotherapy Dose Expansion. o Additional tumor types and doses may be considered upon consultation with the Sponsor. * Approximately 50 patients with CRC, head and neck cancer (H\&N), melanoma, and non-small cell lung cancer (NSCLC) will be enrolled in the Combination Dose Expansion. * A minimum of 8 and a maximum of 10 CRC patients will be enrolled in the Combination Dose Expansion. * Additional tumor types and doses may be considered upon consultation with the Sponsor.
Conditions
- Solid Tumor, Adult
- Advanced Solid Tumor
- Head and Neck Cancer
- Breast Cancer
- Colon Cancer
- Pancreatic Cancer
- Gastric Cancer
- Esophageal Cancer
- Prostate Cancer
- Uterine Cancer
- Cervix Cancer
- Ovarian Cancer
- Kidney Cancer
- Bladder Cancer
- Thyroid Cancer
- Melanoma
- Sarcoma
- Advanced Cancer
- Metastatic Cancer
- Refractory Cancer
- Non Small Cell Lung Cancer
- Merkel Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SNS-101 (anti-VISTA) | SNS-101 IV every 21 days. |
| DRUG | Cemiplimab | Cemiplimab IV every 21 days. |
Timeline
- Start date
- 2023-05-31
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2023-05-18
- Last updated
- 2025-08-15
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05864144. Inclusion in this directory is not an endorsement.