Recent Updates
Recently added Catalysts

LY4052031

Phase 1

Metastatic Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment420
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06465069A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid TumorsPHASE1 RECRUITING 420Jul 1, 2024May 1, 2027May 22, 202633 United States, Australia +6
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031
Cycle 1 (21 Days)

Number of participants with dose-limiting toxicities (DLTs)

Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)
Up to Approximately 48 Months or 4 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Secondary Endpoints
To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
Cycle 1 (21 Days)
To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)
Cycle 1 (21 Days)
To evaluate the preliminary antitumor activity of LY4052031: Overall response rate (ORR)
Up to Approximately 48 Months or 4 Years
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4052031 (Dose-escalation, Cohort A1)EXPERIMENTALEscalating doses of LY4052031 administered intravenously (IV).
LY4052031 (Dose-optimization, Cohort A2)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
LY4052031 (Dose-expansion, Cohort B1, B2, C1)EXPERIMENTALLY4052031 administered IV.
Interventions
NameTypeDescription
LY4052031DRUGIntravenous
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Have one of the following solid tumor cancers: * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinom...

Countries:United StatesAustraliaChinaFranceJapanSouth KoreaSpainUnited Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06465069primaryCompletionDate: changed
LOWMay 24, 2026NCT06465069studyFirstPostDate: changed