About this trial

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 criteria

Qualifiers

Participant must be at least 18 years of age or the age of maturity per local regulations

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 receptor, progesterone receptor, and human epidermal growth factor receptor 2 [HER2] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.

Archival tissue sample for testing

Measurable disease

Disqualifiers

Known symptomatic brain metastases or leptomeningeal metastasis

Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.

Have uncontrolled tumor-associated pain

Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose

Trial design

Treatments tested in this trial

  • IDE034

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

15
Colorado
Sarah Cannon Research Institute at HealthONE80218, Denver United States
Florida
Florida Cancer Specialists34232, Sarasota United States
Michigan
Karmanos Cancer Institute48201, Detroit United States
New York
START New York Long Island, LLC11042, Lake Success United States

Sponsors and collaborators

IDEAYA Biosciences

Lead sponsor