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IDE-161

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |IDEAYA Biosciences, Inc.|Last Updated: Jul 13, 2026

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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment216
FDA Designations
FAST_TRACK
Clinical trial landscape

IDE-161 · 1 trial · 9 indications

Phase 1 1
NCT05787587A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid TumorsAdvanced or Metastatic Solid Tumors
ACTIVE NOT_RECRUITING216 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
Advanced or Metastatic Solid Tumors
NCT05787587216
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Study Endpoints
Primary Endpoints
Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDE
Approximately 2 years

* Incidence of Dose Limiting Toxicities * Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE
Approximately 4 years

* Incidence of treatment-emergent AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing

Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab
Approximately 4 years

Tumor response: Overall Response Rate assessed using RECIST criteria v1.1

Secondary Endpoints
Part 2 (Dose Expansion) Assess the risk/benefit at an IDE161 monotherapy dose and exposure alternative to the initial expansion dose; as well as an IDE161 dose in combination with a fixed dose of pembrolizumab and exposure alternative to the initial
Approximately 4 years
To characterize the single dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Approximately 4 years
To characterize the multiple dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.
Approximately 4 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1 Part 1: Monotherapy Dose EscalationEXPERIMENTALParticipants will be assigned to a dose level.
Module 1 Part 2: Monotherapy Dose ExpansionEXPERIMENTALAfter a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
Module 2 Part 1: Combination Dose Escalation with pembrolizumabEXPERIMENTALParticipants will be assigned to a dose level.
Module 2 Part 2: Combination Dose Expansion with pembrolizumabEXPERIMENTALAfter a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
Interventions
NameTypeDescription
IDE-161DRUGOral Medication
PembrolizumabDRUGIntravenous Infusion
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: 1. Adult participants must be 18 years of age or older 2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors 3. For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterations conferring homologous recombination deficiency...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced or Metastatic Solid Tumors")
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWJul 13, 2026NCT05787587lastUpdatePostDate: changed
LOWJul 13, 2026NCT05787587lastUpdatePostDate: changed
MEDIUMJun 2, 2026NCT05787587Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 2, 2026NCT05787587Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 2, 2026NCT05787587Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT05787587primaryCompletionDate: changed
LOWMay 24, 2026NCT05787587studyFirstPostDate: changed