Can a new antibody help the immune system fight Hard-to-Treat tumors?
NCT ID NCT05864144
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This trial tests an experimental drug called SNS-101, which targets a protein called VISTA that may help tumors evade the immune system. Researchers give SNS-101 alone or with another immunotherapy, cemiplimab, to adults with advanced solid tumors that have not responded to standard care. The study aims to find a safe dose and see whether the drug can shrink tumors. It is an early-phase trial, so the main focus is safety and tolerability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SNS-101, an experimental antibody that targets VISTA, a protein that may help tumors hide from the immune system, given alone or with cemiplimab, another immunotherapy drug.
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not shrink tumors or may cause side effects. The combination with cemiplimab could also increase immune-related reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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98 people
The number who actually took part.
- Started
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May 2023
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Henry Ford Cancer
Detroit, Michigan, 48202, United States
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Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
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NEXT Oncology Dallas
Irving, Texas, 75039, United States
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Norton Healthcare
Louisville, Kentucky, 40202, United States
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START Mountain Region
West Valley City, Utah, 84119, United States
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Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
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South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, 78229, United States
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UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
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University of Colorado Cancer Center - Anschutz Medical
Aurora, Colorado, 80045, United States
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University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
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