Health Trials

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

ConditionsBladder CancerSquamous Cell Carcinoma of the LungEsophageal Squamous Cell CarcinomaTongue Squamous Cell CarcinomaCutaneous Squamous Cell CancerPenile Squamous Cell CarcinomaAnal Squamous Cell CarcinomaVulvar Squamous Cell CarcinomaCervical Squamous Cell CarcinomaVaginal Squamous Cell CarcinomaUrethral Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvolveImmune United, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EVOLVE104
  • EVOLVE104

Treatment groups

160 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Locations

12
California
City of Hope91010, Duarte United States
USC/Norris Comprehensive Cancer Center90033, Los Angeles United States
Connecticut
Yale University Cancer Center06511, New Haven United States
Georgia
The Winship Cancer Institute Emory University30322, Atlanta United States

Sponsors and collaborators

EvolveImmune United, Inc

Lead sponsor

Source ClinicalTrials.gov