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IDE397

Phase 1

Solid Tumor | Small molecule | Oncology |IDEAYA Biosciences, Inc.|Last Updated: Apr 9, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment169
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04794699Study of IDE397 in Participants With Solid Tumors Harboring MTAP DeletionPHASE1 ACTIVE NOT_RECRUITING 169Apr 14, 2021Feb 4, 2027Apr 9, 202637 United States, Australia +5
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Study Endpoints
Primary Endpoints
Dose-limiting Toxicities (DLTs) of IDE397
21 days following the first dose of IDE397

Incidence of DLTs of IDE397 will be determined

Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan
21 - 28 days following the first dose of IDE397

Incidence of DLTs of IDE397 in a combination setting will be determined

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
Approximately 2 years

MTD and RP2D of IDE397 will be determined

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan
Approximately 2 years

MTD and RP2D of IDE397 in a combination setting will be determined

To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms
Approximately 2 years

Objective Response Rate (ORR) and Duration of Response (DoR)

Secondary Endpoints
Plasma Pharmacokinetics of IDE397 and metabolite
Approximately 2 years
Drug interaction between IDE397 and sacituzumab govitecan
Approximately 2 years
Pharmacodynamic effect of IDE397 as a single agent and in combination with sacituzumab govitecan
Approximately 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose Escalation Monotherapy (Solid Tumors)EXPERIMENTAL -
Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial)EXPERIMENTAL -
Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial)EXPERIMENTAL -
Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial)EXPERIMENTAL -
Interventions
NameTypeDescription
IDE397DRUGIDE397 dosed orally
Sacituzumab govitecanDRUGIntravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Participant must be at least 18 years of age * Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy * Have evidence of homozygous loss of MTAP or MTAP deletion * Willing to unde...

Countries:United StatesAustraliaFranceGermanySouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04794699Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT04794699studyFirstPostDate: changed