IDE034 for Advanced Solid Tumors Including Lung, Colorectal, Ovarian and Prostate Cancers

Trial details

Who runs it

IDEAYA Biosciences

Trial code

NCT07503808EU 2026-526299-21-00

Record updated

10 November 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose; Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose; 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; 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; Active uncontrolled infection; 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; Known symptomatic brain metastases or leptomeningeal metastasis; Have uncontrolled tumor-associated pain.

ClinicalTrials.gov NCT07503808 · EU CTIS 2026-526299-21-00