A Study of IDE034 for Advanced Solid Tumors

This study is testing a new drug called IDE034 in adults with advanced solid tumors that have spread (metastatic) or are locally advanced. These tumors must show specific markers called B7-H3 and PTK7. The study aims to find out how safe IDE034 is, what side effects it might cause, and if it can shrink tumors. We are looking for people with certain cancers like esophageal squamous cell carcinoma, high-grade serous ovarian cancer, head and neck squamous cell carcinoma, colorectal cancer, and castration-resistant prostate cancer. The study will first test different doses of IDE034 to find the safest and most effective amount, then expand to more participants to confirm these findings.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 150 participants in total.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for approximately 20 months in total to assess the drug's effects.

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NCT07503808

A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types

Recruiting
PHASE1Ages 18+InterventionalTreatment
IDEAYA Biosciences
~150 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:IDE034

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of IDE034 in Part 1 dose escalation
Measured over 21 days following the first dose of IDE034
+3 more outcomes measured
Esophageal Squamous Cell Carcinoma
High Grade Serous Ovarian Cancer
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Castration-resistant Prostate Cancer
Non Small Cell Lung Cancer
Endometrium Cancer
Triple Negative Breast Cancer
15 sites across 9 states
Texas7
Colorado1
Florida1
Michigan1
New York1
Tennessee1
Utah1
Virginia1

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  • Safety and tolerability of IDE034 in Part 1 dose escalation21 days following the first dose of IDE034

    Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0

  • Safety and tolerability of IDE034 in Part 2 dose expansionApproximately 20 months total study duration

    Incidence of dose limiting toxicities; incidence and severity of AEs and SAEs graded based on CTCAE V6.0

  • To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansionTime Frame: Approximately 20 months total study duration

    Objective Response Rate (ORR) per RECIST v1.1

  • To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansionTime Frame: Approximately 20 months total study duration

    Duration of Response (DoR) per RECIST v1.1