A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types (NCT07503808) | Clinical Trial Compass
RecruitingPhase 1
A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
United States150 participantsStarted 2026-02-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since IDE034 is being tested in a Phase 1 trial, which means the main goal right now is figuring out a safe dose rather than proving it works — what does that mean for my personal risk if I were to consider enrolling?
2This trial covers a wide range of cancer types, including my diagnosis — does my specific cancer's biology or treatment history make me a particularly good or poor fit for what this study is looking for?
3The trial has two parts: a dose escalation phase and a dose expansion phase — which part would I likely be entering, and how does that affect what's known about the risks and potential benefits at the dose I'd receive?
4Are there standard-of-care treatments I haven't tried yet that my care team would recommend I pursue before discussing an early-phase experimental therapy like this one?
5What would my treatment schedule and monitoring requirements look like if I were to participate, and are there logistical demands — like frequency of clinic visits or testing — that I should factor into this conversation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of IDE034 in Part 1 dose escalation
Timeframe: 21 days following the first dose of IDE034
2
Safety and tolerability of IDE034 in Part 2 dose expansion
Timeframe: Approximately 20 months total study duration
3
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Timeframe: Time Frame: Approximately 20 months total study duration
4
To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion
Timeframe: Time Frame: Approximately 20 months total study duration
. Able to comply with contraceptive/barrier requirements
Exclusion criteria
. 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.