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LY3962673

Phase 1

Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Apr 20, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment630
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06586515MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid TumorsPHASE1 RECRUITING 630 — — Sep 12, 2024Mar 1, 2029Apr 20, 202652 United States, Canada +7
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through 5 years

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Phase 1a: Number of Participants with DLT
During the first 28-day cycle of LY3962673 treatment
Phase 1a: Number of Participants with DLT Equivalent Toxicities
During the first 28-day cycle of LY3962673 treatment
Phase 1b: Overall Response Rate (ORR)
Up to approximately 5 years

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

Phase 1b: Best Overall Response (BOR)
Up to approximately 5 years

BOR per investigator assessed RECIST 1.1

Phase 1b: Duration of Response (DOR)
Up to approximately 5 years

DOR per investigator assessed RECIST 1.1

Phase 1b: Time to Response (TTR)
Up to approximately 5 years

TTR per investigator assessed RECIST 1.1

Phase 1b: Disease Control Rate (DCR)
Up to approximately 5 years

DCR per investigator assessed RECIST 1.1

Secondary Endpoints
Phase 1a: Overall Response Rate (ORR)
Up to approximately 5 years
Best Overall Response (BOR)
Up to approximately 5 years
Duration of Response (DOR)
Up to approximately 5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a: LY3962673 Dose EscalationEXPERIMENTALEscalating doses of LY3962673 administered orally.
Phase 1b: LY3962673 Dose ExpansionEXPERIMENTALLY3962673 administered orally either alone or in combination with other chemotherapy agents.
Experimental: Phase 1a: LY3962673 MonotherapyEXPERIMENTALLY3962673 administered orally
Interventions
NameTypeDescription
LY3962673DRUGAdministered orally.
CetuximabDRUGAdministered intravenously.
GemcitabineDRUGAdministered intravenously.
nab-paclitaxelDRUGAdministered intravenously.
OxaliplatinDRUGAdministered intravenously.
leucovorinDRUGAdministered intravenously.
IrinotecanDRUGAdministered intravenously.
5-fluorouracilDRUGAdministered intravenously.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Have evidence of KRAS G12D mutation in tumor tissue or circulating tu...

Countries:United StatesCanadaChinaFranceGermanyIrelandItalyJapanSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06586515primaryCompletionDate: changed
LOWMay 24, 2026NCT06586515studyFirstPostDate: changed