A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
27 sites across 20 statesStudy leadership
- Darrin Beaupre, MD,PhD · STUDY_DIRECTOR · IDEAYA Biosciences
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDEApproximately 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 RDEApproximately 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 pembrolizumabApproximately 4 years
Tumor response: Overall Response Rate assessed using RECIST criteria v1.1