Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDE574 · 1 trial · 4 indications
incidence of DLT; incidence and severity of AEs/serious adverse events (SAEs) graded based on CTCAE V6.0
Incidence and severity of AEs/SAEs graded based on CTCAE V6.0
Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Incidence of DLT; incidence and severity of AEs/SAEs graded based on CTCAE V6.0
Incidence and severity of AEs/SAEs graded based on CTCAE V6.0
Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
| Arm | Type | Description |
|---|---|---|
| Monotherapy Dose Escalation (Part 1A) | EXPERIMENTAL | Participants with the appropriate tumor types will be treated with escalating doses of IDE574 |
| Monotherapy Dose Expansion (Part 1B) | EXPERIMENTAL | Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen monotherapy dose(s) of IDE574 |
| Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant | EXPERIMENTAL | Participants with ER+ HER2- advanced or metastatic breast cancer will be treated with escalating doses of IDE574 in combination with fulvestrant |
| Combination Dose Expansion (Part 2B) | EXPERIMENTAL | Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen combination dose(s) of IDE574 + Fulvestrant |
| Name | Type | Description |
|---|---|---|
| IDE574 | DRUG | IDE574 |
| Fulvestrant injection | DRUG | Fulvestrant Injection |
Inclusion Criteria: Archival Tissue sample for testing * Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on/after at least one line of standard of care therapy or are intolerant to additional effective ...
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IDE574 is an investigational small molecule being studied in adults with advanced solid tumors, including ER+, HER2- breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite stable colorectal carcinoma. It is in Phase 1 clinical development and is not yet approved for any indication.
IDE574 targets KAT6 and KAT7, which are protein targets. By inhibiting these enzymes, IDE574 is designed to interfere with processes that support tumor cell growth. The KAT6/7 mechanism is being evaluated in a Phase 1 study in advanced solid tumors.
IDE574 is being developed by IDEAYA Biosciences, Inc., which trades on the Nasdaq under the ticker IDYA. The company is running a Phase 1 study of the drug in adult participants with advanced solid tumors.
IDE574 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA for any indication. The ongoing Phase 1 trial is currently recruiting participants.
IDE574 is being evaluated in a single Phase 1 trial, NCT07540572, titled A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors. The trial is recruiting, with an estimated enrollment of 160 participants, and is conducted in the United States.
Yes, the Phase 1 trial of IDE574 is biomarker-selected. The study enrolls adults with advanced solid tumors, including ER+, HER2- breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite stable colorectal carcinoma, and uses a controlled design.