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EVOLVE104

Phase 1

Bladder Cancer | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07217171A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell CarcinomasPHASE1 RECRUITING 160 — — Nov 13, 2025Jan 29, 2031Jun 3, 202610 United States
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Study Endpoints
Primary Endpoints
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Baseline, through study completion, an average of 10 months.

TEAEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability

Number of patients with Dose Limiting Toxicities (DLTs)
Baseline, through study completion, an average of 10 months.

Protocol-defined potential DLTs will be assessed by the Safety Review Committee at routine intervals.

To determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) for EVOLVE104
Baseline, through study completion, an average of 10 months.

Safety evaluations will occur consistently for each subject and across patients to assess MTD or RDE. Evaluations include analysis of TEAEs as well as ongoing assessments of laboratories, ECGs and physical examinations.

To determine the recommended phase 2 dose (RP2D) of EVOLVE104
Safety evaluations will be done as described above. PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.

Selection of the RP2D will be based on the aggregate safety, efficacy, PK, and PD observations for the entire study

Secondary Endpoints
Assess the efficacy of EVOLVE104
Baseline, through study completion, an average of 10 months.
Evaluate the Cmax of EVOLVE104
PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.
Evaluate the Tmax of EVOLVE104
PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a Cohort 1; dose level 1EXPERIMENTALActive Study Drug
Phase 1a Cohort 2; dose level 2EXPERIMENTALActive Study Drug
Phase 1a Cohort 3; dose level 3EXPERIMENTALActive Study Drug
Phase 1a Cohort 4; dose level 4EXPERIMENTALActive Study Drug
Phase 1a Cohort 5; dose level 5EXPERIMENTALActive Study Drug
Phase 1a Cohort 6; dose level 6EXPERIMENTALActive Study Drug
Phase 1a Cohort 7; dose level 7EXPERIMENTALActive Study Drug
Phase 1a Cohort 8; dose level 8EXPERIMENTALActive Study Drug
Phase 1a Cohort 9; dose level 9EXPERIMENTALActive Study Drug
Phase 1a Cohort 10; dose level 10EXPERIMENTALActive Study Drug
Phase 1b Cohort 1; dose level TBDEXPERIMENTALActive study drug
Phase 1b Cohort 2; dose level TBDEXPERIMENTALActive study drug
Interventions
NameTypeDescription
EVOLVE104DRUGEVOLVE104 is provided as a solution for injection via IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United States
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Competitive Landscape -Bladder Cancer 147 trials
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Johnson & JohnsonJNJ13PHASE3TAR-200, Mitomycin C, Gemcitabine, Cetrelimab, BCG Vesiculture
Merck & Co., Inc.MRK13PHASE3Pembrolizumab, BCG, Cisplatin, Fluorouracil, Mitomycin C
Pfizer Inc.PFE10PHASE3PF-06801591, Bacillus Calmette-Guerin, Avelumab, Lorlatanib, Talazoparib
Eli Lilly and CompanyLLY4PHASE3Vepugratinib, EV, Pembrolizumab, LY4101174, LY4052031
UroGen Pharma Ltd.URGN4PHASE3UGN-103, UGN-102, UGN-104, Jelmyto for pyelocalyceal
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Tyra Bioscience, IncTYRA3PHASE2Dabogratinib, Dabogratinib TBD, TYRA-300, TYRA-300 Dose TBD
BioNTech SE Sponsored ADRBNTX1PHASE2Autogene Cevumeran, Nivolumab, Saline
ICON PlcICLR1PHASE3padeliporfin VTP
AbbVie, Inc.ABBV1PHASE2Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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