Trial Title:
A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
NCT ID:
NCT05864144
Condition:
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
Conditions: Official terms:
Carcinoma, Merkel Cell
Neoplasms
Kidney Neoplasms
Uterine Neoplasms
Uterine Cervical Neoplasms
Cemiplimab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SNS-101 (anti-VISTA)
Description:
SNS-101 IV every 21 days.
Arm group label:
Part A - SNS-101 Monotherapy Dose Escalation and Dose Expansion
Arm group label:
Part B - SNS-101 in combination with cemiplimab and Dose Expansion
Arm group label:
Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab
Intervention type:
Drug
Intervention name:
Cemiplimab
Description:
Cemiplimab IV every 21 days.
Arm group label:
Part B - SNS-101 in combination with cemiplimab and Dose Expansion
Arm group label:
Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimab
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Histologically or cytologically documented locally advanced, unresectable or
metastatic solid tumor.
- Having received and failed or was intolerant to standard of care for advanced
disease or not eligible for standard of care therapy with the following tumor types
for patients in Phase 1 dose expansion cohorts:
1. Microsatellite Stable (MSS) CRC (both monotherapy and combination cohorts); no
more than 3 lines of prior systemic therapy for metastatic disease.
2. H&N cancer (combination cohort only); no more than 2 lines of prior systemic
therapy for metastatic disease.
3. Melanoma (combination cohort only); no more than 3 lines of prior systemic
therapy for metastatic disease, including at least 1 prior treatment with a
BRAF inhibitor for patients with a BRAF mutation.
4. NSCLC (combination cohort only); no more than 2 lines of prior systemic therapy
for metastatic disease, including at least 1 prior treatment with a targeted
therapy for patients with a mutation such as EGFR, ALK, KRAS, or RET.
5. Patients with H&N cancer, melanoma, and NSCLC (or additional tumor types that
typically respond to PD1/PD-L1 monotherapy) must have received a prior
PD1/PD-L1 where best response was stable disease and progression occurred
during treatment or within 3 months of last dose of PD1/PD-L1.
Additional tumor types and doses may be considered.
- Measurable disease
- ECOG performance status 0 or 1.
- Life expectancy of ≥ 3 months.
- Willing to provide pre-treatment (archival or fresh) and on-treatment tumor biopsy
samples.
- Adequate organ function
- Women of childbearing potential and fertile males with WOCBP partners must use
highly effective contraception during the study and for 180 days after the study.
Patients must agree not to donate eggs (ova, oocytes) or sperm during the study.
Key Exclusion Criteria:
- Use of anti-PD-1/PD-L1 targeting monoclonal antibody therapy, monoclonal antibody
therapy, chemotherapy, biologic, investigational, or radiotherapy within 2 weeks of
Cycle 1 Day 1.
- Clinically significant unresolved toxicities from prior anticancer therapy.
- Grade 3 or higher immune-related adverse event on prior PD-1/PD-L1 blockade or prior
agents targeting stimulatory or co-inhibitory T cell receptor.
- Known other previous/current malignancy requiring treatment within ≤ 2 years except
for limited disease treated with curative intent, such as carcinoma in situ,
squamous or basal cell skin carcinoma, or superficial bladder carcinoma.
- Known asymptomatic or symptomatic brain metastasis or leptomeningeal disease.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins.
- Women who are pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Hematology/Oncology
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Naomi Long
Phone:
310-794-2464
Email:
NELong@mednet.ucla.edu
Facility:
Name:
University of Colorado Cancer Center - Anschutz Medical
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Natalie Biggerstaff
Email:
poemsintake@cuanschutz.edu
Facility:
Name:
Norton Healthcare
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dawn Diehl
Email:
EarlyPhase-NCIResearch@nortonhealthcare.org
Facility:
Name:
Henry Ford Cancer
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Meghan Gauronskas
Phone:
303-693-5904
Email:
mgauron1@hfhs.org
Facility:
Name:
Icahn School of Medicine at Mt. Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniela Delbeau-Zagelbaum, MSN, APRN, AGNP-C, AGCNS-BC
Phone:
212-241-2066
Email:
Daniela.Delbeau@mssm.edu
Facility:
Name:
University of Pennsylvania, Perelman Center for Advanced Medicine
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Biroc, MSN, RN
Phone:
215-220-9699
Email:
Elizabeth.Biroc@pennmedicine.upenn.edu
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Withdrawn
Facility:
Name:
Sanford Cancer Center
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Powell, MD
Phone:
605-328-8000
Contact backup:
Last name:
Staci Vogel
Phone:
605-312-3336
Email:
staci.vogel@sanfordhealth.org
Facility:
Name:
NEXT Oncology Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erica Torres
Phone:
737-610-5180
Email:
etorres@nextoncology.com
Facility:
Name:
South Texas Accelerated Research Therapeutics (START) San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isabel Jimenez, RN, MSN
Phone:
210-593-5265
Email:
isabel.jimenez@startsa.com
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marie Asay
Phone:
801-907-4770
Email:
marie.asay@startthecure.com
Start date:
May 31, 2023
Completion date:
June 2027
Lead sponsor:
Agency:
Sensei Biotherapeutics, Inc.
Agency class:
Industry
Collaborator:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Sensei Biotherapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05864144
