RecruitingPhase 1NCT07503808

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


Sponsor

IDEAYA Biosciences

Enrollment

150 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing IDE034 — a new bispecific antibody-drug conjugate that targets two proteins found on cancer cells (B7-H3 and PTK7) — in adults with advanced or metastatic solid tumors including lung cancer, esophageal cancer, endometrial cancer, ovarian cancer, head and neck cancer, triple-negative breast cancer, colorectal cancer, and prostate cancer. The study starts with dose escalation to find the safest and most effective dose, then expands to test that dose in larger groups of specific cancer types. Adults 18 and older with measurable disease expressing both target proteins, good performance status, and who have received at least one prior therapy are eligible, while those with active brain metastases, severe cardiac or lung disease, or prior treatment with similar drugs are excluded. Participants will receive IDE034 intravenously at scheduled intervals and attend regular visits for safety monitoring and tumor response assessments. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIDE034

IDE034


Locations(5)

NEXT Texas LLC - Austin

Austin, Texas, United States

NEXT Texas LLC - Houston

Houston, Texas, United States

NEXT Texas LLC - Dallas

Irving, Texas, United States

NEXT Texas LLC - San Antonio

San Antonio, Texas, United States

NEXT Texas LLC - Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07503808


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