A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
← catalyst calendarNCT07540572 · readout in 1,319 d
Sponsored by IDEAYA Biosciences (industry) · IDYA — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
160estimated
Sites
11
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 | 2026-03-17 | actual | When the study began enrolling |
| Primary completion | 2030-03-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- ER+, HER 2- Breast Cancer
- Non-small Cell Lung Cancer (NSCLC)
- Castration-resistant Prostate Cancer (CRPC)
- Microsatellite Stable (MSS) Colorectal Carcinoma
Interventions
- Drug: IDE574
- Drug: Fulvestrant injection
Primary outcomes
what the primary-completion date above is the date OFSafety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation
measured 21 days following the first dose of IDE574
Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs/SAEs
measured Approximately 24 months total study duration
To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1
measured Approximately 24 months total study duration
To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1.
measured Approximately 24 months total study duration
Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2A Combination Dose Escalation based on incidence of DLT
measured Approximately 24 months total study duration
Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the incidence and severity of AEs/SAEs
measured Approximately 24 months total study duration
Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the ORR per RECIST version 1.1
measured Time Frame: Approximately 24 months total study duration
Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on DOR per RECIST version 1.1.
measured Time Frame: Approximately 24 months total study duration
Permalink · IDYA's whole pipeline · Catalyst calendar · Every registered study · What changed