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EVOLVE104

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

EVOLVE104 · 1 trial · 11 indications

Phase 1 1
NCT07217171A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell CarcinomasBladder Cancer
RECRUITING160 Analytics
PHASE1RECRUITING
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Bladder Cancer
NCT07217171160
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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 to 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 145 trials

Top 20 of 46 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN15PHASE3Durvalumab, Bacillus Calmette-Guerin
Bristol-Myers Squibb CompanyBMY5PHASE3Nivolumab, Gemcitabine, Cisplatin
Johnson & JohnsonJNJ12PHASE3TAR-200, Mitomycin C, Gemcitabine
Merck & Co., Inc.MRK14PHASE3Pembrolizumab, BCG
Pfizer Inc.PFE10PHASE3PF-06801591, Bacillus Calmette-Guerin
Eli Lilly and CompanyLLY4PHASE3Vepugratinib, EV, Pembrolizumab
Natera, Inc.NTRA2PHASE3Atezolizumab
UroGen Pharma Ltd.URGN4PHASE3UGN-103
CG Oncology, Inc.CGON2PHASE3Cretostimogene Grenadenorepvec
Protara Therapeutics, Inc.TARA2PHASE3TARA-002
Relmada Therapeutics IncRLMD2PHASE3NDV-01
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Tislelizumab, Cisplatin, Gemcitabine, Carboplatin
ImmunityBio IncIBRX6PHASE2N-803 and BCG
Exelixis, Inc.EXEL4PHASE2Cabozantinib, Atezolizumab
ICON PlcICLR1PHASE3padeliporfin VTP
Gilead Sciences, Inc.GILD2PHASE2Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab
Tyra Bioscience, IncTYRA3PHASE2Dabogratinib, Dabogratinib TBD
BioNTech SE Sponsored ADRBNTX1PHASE2Autogene Cevumeran, Nivolumab
AbbVie, Inc.ABBV1PHASE2Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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Frequently asked questions about EVOLVE104

What is EVOLVE104 used for?

EVOLVE104 is an investigational small molecule being developed for the treatment of bladder cancer. It is currently being evaluated in a Phase 1 clinical trial for advanced urothelial and squamous cell carcinomas, including bladder cancer and several other squamous cell carcinoma types.

Who makes EVOLVE104?

EVOLVE104 is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol UTHR. The company is currently conducting a Phase 1 clinical trial to evaluate the drug's safety, efficacy, and pharmacokinetics.

What phase is EVOLVE104 in?

EVOLVE104 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is currently recruiting participants in the United States.

What clinical trials is EVOLVE104 in?

EVOLVE104 is being studied in one active Phase 1 clinical trial with the identifier NCT07217171. This trial is evaluating the safety, efficacy, and pharmacokinetics of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas, with a planned enrollment of 160 participants.

What does EVOLVE104 target?

The specific molecular target of EVOLVE104 has not been disclosed. The drug is being studied in a biomarker-selected patient population, indicating that the trial may use biomarkers to identify participants most likely to benefit from treatment.