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New drug EVOLVE104 takes on tough cancers in early human trial

NCT ID NCT07217171

Disease control Sponsor: EvolveImmune United, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 10 times

Summary

This early-stage trial is testing an experimental drug called EVOLVE104 in people with advanced bladder cancer or several types of squamous cell carcinoma (lung, esophagus, skin, and others). The study aims to find a safe dose and see if the drug can shrink tumors. It is for patients who have already tried standard treatments or cannot take them. About 160 participants will receive the drug by IV infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EVOLVE104 (an experimental drug given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for advanced bladder and squamous cell cancers that have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 160 participants, so the drug may not prove effective or safe enough for wider use. Side effects are unknown and could be serious.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

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: Participants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma. 1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type. 2. The cancer must be measurable by CT scan or MRI. 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1. 4. Anticipated life expectancy of at least 3 months. 5. Adequate organ function, as indicated by standard blood tests. 6. Able to provide a fresh or archival tumor biopsy. 7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile. Key Exclusion Criteria: 1. The participant is a candidate for treatment with a targeted agent known to provide a benefit. 2. Persistent significant toxicities from prior anticancer therapy. 3. Brain metastases unless previously treated and stable. 4. Prior severe or life-threatening immunologic reactions to previous therapies. 5. Significant medical conditions, including but not limited to: * History of clinically significant cardiac disease * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis. * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations. * History of cirrhosis or significant portal hypertension. * Uncontrolled or significant infection. * History of certain other cancers in the past 3 years. * History of arterial thrombosis, stroke and transient ischemic attack within 6 months. * Active or uncontrolled HIV, HBV or HCV infection. * Autoimmune or other condition requiring chronic systemic immunosuppression.

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Conditions

The condition(s) this trial relates to.

anal squamous cell carcinoma anus neoplasm cervical squamous cell carcinoma esophageal squamous cell carcinoma skin squamous cell carcinoma squamous cell carcinoma squamous cell carcinoma of penis squamous cell lung carcinoma tongue squamous cell carcinoma urethra squamous cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma vaginal squamous cell carcinoma vulvar squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal squamous cell carcinoma Bladder cancer Cervical squamous cell carcinoma Cutaneous squamous cell cancer Esophageal squamous cell carcinoma Penile squamous cell carcinoma Squamous cell carcinoma of the lung Tongue squamous cell carcinoma Urethral squamous cell carcinoma Vaginal squamous cell carcinoma Vulvar squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Medical Center - Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • SCRI

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • The Winship Cancer Institute Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UCSF Medical center Parnassus

    RECRUITING

    San Francisco, California, 94158, United States

  • USC/Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Yale University Cancer Center

    RECRUITING

    New Haven, Connecticut, 06511, United States

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