NCT07503808

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

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: IDEAYA Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.

Detailed description

Part 1 - Dose escalation Part 1 will evaluate increasing doses of IDE034 to assess safety, tolerability, and to determine dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in subjects with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7. Part 2 - Dose Expansion Part 2 will evaluate participants with B7-H3 and PTK7 expressing advanced/metastatic solid tumors at 2 or more dose levels determined to be safe and tolerable during dose escalation. The goal of Part 2 is to identify which of the doses evaluated in Part 1 is safe, well tolerated and results in tumor responses. In parallel a basket cohort may be enrolled at one of the expansion dose(s) for which the tumor types and other selection criteria will be based on emerging data from nonclinical and Part 1 clinical evaluations. Additional selection criteria may be applied to the expansion indications (e.g., histological subset or select molecular alterations) based on emerging data.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	IDE034	IDE034

Timeline

• Start date: 2026-02-24
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study