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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07503808

Run by

IDEAYA Biosciences

People needed

150

Starts

2026-02-24

Expected to finish

2027-07-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Have adequate bone marrow and organ function.
• Able to comply with contraceptive/barrier requirements

You may not qualify if…

• 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
• Active uncontrolled infection
• Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.
• Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.
• Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.
• Participants with known or suspected viral hepatitis
• Have history of active tuberculosis within 1 year before enrollment
• If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms
• Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP
• Administration of any of the following
• Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
• Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).
• Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP
• Have received radiotherapy within 2 weeks prior to study entry
• Have undergone major surgery or trauma within 4 weeks prior to study entry.
• Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.
• Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.
• Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody/fusion protein drugs.
• Participants with complications in the eye including ulcers in the eye, and severe dry eye

Where it is running

• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• START New York Long Island, LLC — Lake Success, New York, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• NEXT Texas LLC - Austin — Austin, Texas, United States (enrolling)
• START Dallas Fort Worth, LLC — Fort Worth, Texas, United States (enrolling)
• MD Anderson — Houston, Texas, United States (enrolling)
• NEXT Texas LLC - Houston — Houston, Texas, United States (enrolling)
• NEXT Texas LLC - Dallas — Irving, Texas, United States (enrolling)
• NEXT Texas LLC - San Antonio — San Antonio, Texas, United States (enrolling)
• START San Antonio, LLC — San Antonio, Texas, United States (enrolling)
• START Mountain Region, LLC — West Valley City, Utah, United States (enrolling)
• NEXT Texas LLC - Virginia — Fairfax, Virginia, United States (enrolling)
• Medical Oncology Associates — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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