IDE034 for Advanced Solid Tumors Including Lung, Colorectal, Ovarian and Prostate Cancers
Tests IDE034 in adults with advanced solid tumors that carry B7-H3 and PTK7.
Plain-language title generated from the registry record
Registry title: A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
Key facts
- Where
- Batumi and Tbilisi, GeorgiaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors that carry the markers B7-H3 and PTK7, whose cancer has grown or returned after at least one earlier treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced, recurrent or metastatic solid tumors: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC, CRC or CRPC. The disease must be measurable on scans. ECOG performance status must be 0 or 1.
- Earlier treatment
- The cancer must have grown or returned after at least one line of therapy, or the person cannot tolerate other effective standard treatments. Prior B7-H3 or PTK7 antibody-drug conjugate treatment is not allowed.
- Biomarker or test result
- The tumor must express B7-H3 and PTK7. An archival tissue sample is needed for testing. For TNBC, the tumor must be negative for estrogen receptor, progesterone receptor and HER2.
Main reasons for not taking part
- Symptomatic brain or leptomeningeal metastases
- Another cancer within 2 years before the first dose
- Positive HIV test, known or suspected viral hepatitis, or active uncontrolled infection
- History of interstitial pneumonitis or other serious lung disease
- Pregnant or breastfeeding women
Read by machine on 11 November 2026.
Where in Georgia
- LTD High Technology Hospital MedcenterBatumi, GeorgiaTaking people
- Multiprofile Clinic Consilium MedullaTbilisi, GeorgiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.