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New treatment option for Esophageal Squamous Cell Carcinoma
Official title A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
ClinicalTrials.gov ID: NCT07503808
What this study is testing
What is IDE034?
IDE034 is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Archival tissue sample for testing
- Measurable disease
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
You likely can't join 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...
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Sarasota, Florida, United States
- Detroit, Michigan, United States
- Lake Success, New York, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Sarasota, Florida, United States; Detroit, Michigan, United States; Lake Success, New York, United States; Nashville, Tennessee, United States; Austin, Texas, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.