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RecruitingPhase 1

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

A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe EVOLVE104 is, how well it works, and how the body handles it. It is for people with certain advanced cancers who have had standard treatments, turned them down, or could not receive them.

The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cancer that has spread nearby or to other parts of the body: bladder cancer or squamous cell cancer of the lung, food pipe, skin, anus, or genitals.
  • Have records showing the cancer got worse during or after standard treatment, based on the cancer type.
  • Have cancer that can be measured on a CT or MRI scan.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Be expected to live at least 3 months.
  • Have blood tests showing that organs are working well enough.
  • Be able to provide a new or stored tumor tissue sample.
  • Agree to use birth control during the study and for 120 days after the last dose. Women who have gone through menopause or had surgery that prevents pregnancy do not need to use it.

Who can't join

  • Can receive a targeted cancer drug known to help treat your cancer.
  • Still have major side effects from past cancer treatment, or had a severe or life-threatening immune reaction to past treatment.
  • Have cancer that has spread to the brain, unless it was treated and is stable.
  • Have serious heart disease, or had a blood clot in an artery, stroke, or mini-stroke in the past 6 months.
  • Have severe damage to the food pipe, such as a tear or severe inflammation that wears away its lining; or active inflammation, damage, or sores on the eye's surface or lining.
  • Have a history of liver scarring or high pressure in the blood vessels leading to the liver.
  • Have a serious or uncontrolled infection, including active or uncontrolled HIV, hepatitis B, or hepatitis C.
  • Have had certain other cancers in the past 3 years, or have an immune system disease or another condition needing long-term medicine that lowers immune activity throughout the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (16)

CA

CT

GA

MI

NC

NY

OH

PA

TN

TX

VA