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 for the treatment of ER+, HER2- breast cancer, as well as other advanced solid tumors including non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite stable colorectal carcinoma. It is currently in Phase 1 clinical development.
IDE574 targets KAT6/7, which are proteins involved in epigenetic regulation. By inhibiting these targets, the drug is being investigated for its potential anti-tumor activity in advanced solid tumors. The drug is being developed as a small molecule therapy.
IDE574 is being developed by IDEAYA Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IDYA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
IDE574 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety, pharmacokinetics, and preliminary efficacy.
IDE574 is being studied in a Phase 1 clinical trial with the identifier NCT07540572. The trial is titled 'A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors' and is currently recruiting in the United States.
Yes, IDE574 is being studied in ER+, HER2- breast cancer as part of a Phase 1 clinical trial. The trial also includes patients with non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite stable colorectal carcinoma. The study is enrolling adult participants aged 18 years and older.