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

RecruitingPhase 1Ages 18 Years - anyAllEvolveImmune United, Inc
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค1. 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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What it tests

  • EVOLVE104
  • EVOLVE104
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Where

16 sites
City of Hope
Duarte, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, United States
UCSF Medical center Parnassus
San Francisco, United States
Yale University Cancer Center
New Haven, United States
The Winship Cancer Institute Emory University
Atlanta, United States
START Midwest
Grand Rapids, United States
Icahn School of Medicine at Mount Sinai
New York, United States
Columbia University Irving Medical Center
New York, United States

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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