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

Study Identifier:
EIU-104101
CT.gov Identifier:
NCT07217171
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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.

Study objectives include assessing the safety, efficacy, pharmacokinetics and pharmacodynamics of EVOLVE104 and identifying the recommended phase 2 dose (RP2D).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Other Lung Cancer
  • Esophageal
  • Tongue
  • Squamous Cell Carcinoma
  • Penile
  • Bowel (Colorectal)
  • Vulvar
  • Cervical cancer
  • Vaginal
  • Urethral
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a Cohort 1; dose level 1
    • Read More
  • Drug: Experimental: Phase 1a Cohort 2; dose level 2
  • Drug: Experimental: Phase 1a Cohort 3; dose level 3
  • Drug: Experimental: Phase 1a Cohort 4; dose level 4
  • Drug: Experimental: Phase 1a Cohort 5; dose level 5
  • Drug: Experimental: Phase 1a Cohort 6; dose level 6
  • Drug: Experimental: Phase 1a Cohort 7; dose level 7
  • Drug: Experimental: Phase 1a Cohort 8; dose level 8
  • Drug: Experimental: Phase 1a Cohort 9; dose level 9
  • Drug: Experimental: Phase 1a Cohort 10; dose level 10
  • Drug: Experimental: Phase 1b Cohort 1; dose level TBD
  • Drug: Experimental: Phase 1b Cohort 2; dose level TBD
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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.
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Bladder
    Other Lung Cancer
    Esophageal
    Tongue
    Squamous Cell Carcinoma
    Penile
    Bowel (Colorectal)
    Vulvar
    Cervical cancer
    Vaginal
    Urethral