Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 1: testing IDE034 for Esophageal Squamous Cell Carcinoma
This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to measure the safety, PK, immunogenicity and preliminary how well it works of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are IDE034. The registry lists allocation as randomized. This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to measure the safety, PK, immunogenicity and preliminary how well it works of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.
They plan to enroll about 150 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Interventions: IDE034
Primary outcome (registry wording): Safety and tolerability of IDE034 in Part 1 dose escalation
Who it is for (from inclusion criteria)
Ages 18 Years to any
Participant must be at least 18 years of age or the age of maturity per local regulations
Archival tissue sample for testing
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
Who the registry excludes
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 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
Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer, or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are benign (non-cancerous) tumors arising from smooth muscle.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07503808?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07503808?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.