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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas

Testing EVOLVE104 for safety and effectiveness in advanced cancer patients.

Recruiting
18 years and older
All
Phase 1

This study is testing a new drug called EVOLVE104 for people with advanced types of cancer such as bladder, lung, or skin cancer. The study aims to check if this drug is safe and works effectively for patients who have already tried other treatments or cannot take them. There are two stages in the study, and around 160 people will participate. In the first stage, the dose of the drug will be gradually increased to find the best amount, and in the second stage, more participants will be added to further examine the drug's effects.

Participants will receive the drug for about 10 months or until they can no longer continue due to reasons like the cancer getting worse or experiencing side effects. To join, participants need to have measurable cancer, good organ health, and agree to use birth control.

  • The study lasts for about 10 months.
  • Participants need to visit the clinic regularly for check-ups.
  • Participants must meet specific health criteria to join.
Study details
    Bladder Cancer
    Squamous Cell Carcinoma of the Lung
    Esophageal Squamous Cell Carcinoma
    Tongue Squamous Cell Carcinoma
    Cutaneous Squamous Cell Cancer
    Penile Squamous Cell Carcinoma
    Anal Squamous Cell Carcinoma
    Vulvar Squamous Cell Carcinoma
    Cervical Squamous Cell Carcinoma
    Vaginal Squamous Cell Carcinoma
    Urethral Squamous Cell Carcinoma

NCT07217171

EvolveImmune United, Inc

17 October 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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