Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDE034 · 1 trial · 8 indications
Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0
Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0
Objective Response Rate (ORR) per RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Part 1:IDE034 Dose Escalation | EXPERIMENTAL | IDE034 Dose Escalation Successive cohorts of participants will be treated with increasing doses of IDE034 until the maximum tolerated dose or the recommended dose for expansion is determined |
| Part 2: IDE034 Dose Expansion | EXPERIMENTAL | IDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation |
| Name | Type | Description |
|---|---|---|
| IDE034 | DRUG | IDE034 |
Inclusion Criteria: 1. Participant must be at least 18 years of age or the age of maturity per local regulations 2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen r...
IDE034 is an investigational small molecule developed by IDEAYA Biosciences, Inc. for the treatment of advanced solid tumors, including esophageal squamous cell carcinoma. It is being studied in a Phase 1 clinical trial and has not been approved by the FDA. IDE034 is designed as a targeted cancer therapy for patients with locally advanced or metastatic disease.
IDE034 targets B7H3 and PTK7, two proteins expressed on tumor cells. By binding these targets, IDE034 is designed to act on cancer cells in solid tumors. Both B7H3 and PTK7 are protein targets, and the drug is a small molecule being evaluated in biomarker-selected patients with advanced malignancies.
IDE034 is being evaluated for the treatment of esophageal squamous cell carcinoma, a type of cancer affecting the esophagus. It is also being studied in other advanced solid tumors. IDE034 remains investigational and is not approved for any indication; it is available only through clinical trial participation for eligible patients.
IDE034 is developed by IDEAYA Biosciences, Inc., a biotechnology company whose common stock trades on the Nasdaq under the ticker symbol IDYA. IDEAYA is the sponsor responsible for the clinical development of IDE034, including its ongoing Phase 1 study in patients with locally advanced or metastatic solid tumors.
IDE034 is in Phase 1 clinical development. The single ongoing trial is currently recruiting participants and has an planned enrollment of 150 patients. IDE034 has not completed any trials and is not FDA approved; it remains an investigational agent being tested for safety and tolerability in advanced solid tumors.
IDE034 is being studied in one active clinical trial, NCT07503808, titled A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types. The Phase 1 trial is recruiting in the United States and enrolls adults aged 18 years and older, including patients with esophageal squamous cell carcinoma and other solid tumors.