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

Part of paid clinical trials in Los Angeles, California.

Sponsor
EvolveImmune United, Inc
Study ID
NCT07217171
Phase
PHASE1
Status
Recruiting
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Conditions

  • Anal Squamous Cell Carcinoma
  • Bladder Cancer
  • Cervical Squamous Cell Carcinoma
  • Cutaneous Squamous Cell Cancer
  • Esophageal Squamous Cell Carcinoma
  • Penile Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Lung
  • Tongue Squamous Cell Carcinoma
  • Urethral Squamous Cell Carcinoma
  • Vaginal Squamous Cell Carcinoma
  • Vulvar Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EVOLVE104 — DRUG
    EVOLVE104 is provided as a solution for injection via IV infusion
  • EVOLVE104 — DRUG
    Dose levels for Phase 1b will be determined based on the outcome of Phase 1a

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
Jun 2026
Primary completion
Jan 29, 2029
Completion
Jan 29, 2031

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Cohort 1; dose level 1
    Active Study Drug
  • Experimental: Phase 1a Cohort 2; dose level 2
    Active Study Drug
  • Experimental: Phase 1a Cohort 3; dose level 3
    Active Study Drug
  • Experimental: Phase 1a Cohort 4; dose level 4
    Active Study Drug
  • Experimental: Phase 1a Cohort 5; dose level 5
    Active Study Drug
  • Experimental: Phase 1a Cohort 6; dose level 6
    Active Study Drug
  • Experimental: Phase 1a Cohort 7; dose level 7
    Active Study Drug
  • Experimental: Phase 1a Cohort 8; dose level 8
    Active Study Drug
  • Experimental: Phase 1a Cohort 9; dose level 9
    Active Study Drug
  • Experimental: Phase 1a Cohort 10; dose level 10
    Active Study Drug
  • Experimental: Phase 1b Cohort 1; dose level TBD
    Active study drug
  • Experimental: Phase 1b Cohort 2; dose level TBD
    Active study drug

Primary Outcome Measure

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline, through study completion, an average of 10 months. ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Yale University Cancer CenterNew HavenConnecticut06511
The Winship Cancer Institute Emory UniversityAtlantaGeorgia30322
START MidwestGrand RapidsMichigan49546
Columbia University Irving Medical CenterNew YorkNew York10032
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107
SCRINashvilleTennessee37203
MD Anderson Cancer CenterHoustonTexas77030
Virginia Cancer SpecialistsFairfaxVirginia22031

Find similar trials in Los Angeles, CA

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By research site
USC/Norris Comprehensive Cancer Center· Los Angeles, CAYale University Cancer Center· New Haven, CTThe Winship Cancer Institute Emory University· Atlanta, GASTART Midwest· Grand Rapids, MIColumbia University Irving Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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