A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
← catalyst calendarNCT05787587 · readout ≤ 73 d
Sponsored by IDEAYA Biosciences (industry) · IDYA — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
216estimated
Sites
27
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-04-18 | actual | When the study began enrolling |
| Primary completion | Oct 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced or Metastatic Solid Tumors
- Breast Cancer
- Ovarian Cancer
- Prostate Cancer
- Endometrial Cancer
- Colorectal Cancer
- Head and Neck Cancers
- Extensive Stage Small Cell Lung Cancer (ES-SCLC)
- NSCLC
Interventions
- Drug: IDE-161
- Drug: Pembrolizumab — also filed as KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFPart 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDE
measured Approximately 2 years
Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE
measured Approximately 4 years
Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab
measured Approximately 4 years
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