Can a new antibody help the immune system fight Hard-to-Treat tumors?

NCT ID NCT05864144

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

98 people

The number who actually took part.

Started

May 2023

Finished

Jun 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Henry Ford Cancer

    Detroit, Michigan, 48202, United States

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029, United States

  • NEXT Oncology Dallas

    Irving, Texas, 75039, United States

  • Norton Healthcare

    Louisville, Kentucky, 40202, United States

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104, United States

  • South Texas Accelerated Research Therapeutics (START) San Antonio

    San Antonio, Texas, 78229, United States

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095, United States

  • University of Colorado Cancer Center - Anschutz Medical

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania, Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

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