BridgeMD
Tests treatment safety and results for Bladder Cancer
Official title A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
ClinicalTrials.gov ID: NCT07217171
What this study is testing
What is EVOLVE104?
EVOLVE104 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key Participants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of...
- Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.
- The cancer must be measurable by CT scan or MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.
- Anticipated life expectancy of at least 3 months.
You likely can't join if
- The participant is a candidate for treatment with a targeted agent known to provide a benefit.
- Persistent significant toxicities from prior anticancer therapy.
- Brain metastases unless previously treated and stable.
- Prior severe or life-threatening immunologic reactions to previous therapies.
- Significant medical conditions, including but not limited to:
- History of clinically significant cardiac disease
See the full eligibility criteria
- Key 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.
- Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.
- The cancer must be measurable by CT scan or MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.
- Anticipated life expectancy of at least 3 months.
- Adequate organ function, as indicated by standard blood tests.
- Able to provide a fresh or archival tumor biopsy.
- 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
- The participant is a candidate for treatment with a targeted agent known to provide a benefit.
- Persistent significant toxicities from prior anticancer therapy.
- Brain metastases unless previously treated and stable.
- Prior severe or life-threatening immunologic reactions to previous therapies.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Grand Rapids, Michigan, United States; New York, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.