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IDE034

Phase 1

Esophageal Squamous Cell Carcinoma | Small molecule | Oncology |IDEAYA Biosciences, Inc.|Last Updated: Mar 31, 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 Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07503808A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors TypesPHASE1 RECRUITING 150Feb 24, 2026Jul 30, 2027Mar 31, 20265 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of IDE034 in Part 1 dose escalation
21 days following the first dose of IDE034

Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0

Safety and tolerability of IDE034 in Part 2 dose expansion
Approximately 20 months total study duration

Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0

To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Time Frame: Approximately 20 months total study duration

Objective Response Rate (ORR) per RECIST v1.1

Secondary Endpoints
To evaluate preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 1 dose escalation
Approximately 20 months total study duration
To further characterize preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Approximately 20 months total study duration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1:IDE034 Dose EscalationEXPERIMENTALIDE034 Dose Escalation Successive cohorts of participants will be treated with increasing doses of IDE034 until the maximum tolerated dose or the recommended dose for expansion is determined
Part 2: IDE034 Dose ExpansionEXPERIMENTALIDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation
Interventions
NameTypeDescription
IDE034DRUGIDE034
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Participant must be at least 18 years of age or the age of maturity per local regulations 2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen r...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07503808primaryCompletionDate: changed
LOWMay 24, 2026NCT07503808studyFirstPostDate: changed