A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (NCT07174583)
A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including Small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (30 items).
Location: Sarah Cannon Research Institute at HealthONE — Denver, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Have mixed SCLC and NSCLC histology are not allowed (SCLC with components of large cell NEC are eligible). Participants with limited stage SCLC are ineligible.
- Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.
- Have had other malignancies within 2 years prior to the first dose, except adequately treated carcinoma in situ (cervical, breast, or other), basal cell or squamous cell skin cancer, localized prostate cancer after curative therapy with no recurrence, or papillary thyroid cancer after curative resection; other prior or concurrent malignancies may be eligible with Medical Monitor review and approval.
- Have uncontrolled tumor-associated pain.
- Have severe cardiovascular and cerebrovascular disease
- Have history of clinically significant bleeding within 3 months before the first study dose.
- Have history of interstitial pneumonitis during previous treatment; 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, including, but not limited to, idiopathic pulmonary fibrosis and organizing pneumonia/obliterative bronchiolitis.
- Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening (HIV antibody positive and HIV-RNA above the lower limit of detection of the analytical method).
- Subjects with known or suspected viral hepatitis.
- Have a history of active tuberculosis within 1 year before enrollment.
- For participants enrolling to receive the combination with durvalumab, must not be deemed by the Investigator to be unsuitable to receive immunotherapy, or have had any prior intolerance to PD-1/PD-L1 inhibitor therapy, or have had any prior Grade 2 or higher myocarditis or any other Grade 3 or higher immune-related AE. If the participant has had a prior immune-related AE, must have recovered to Grade \< 1.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (13 Sites)
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado
- Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando, Florida
- Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne North Office — Fort Wayne, Indiana
- START Midwest — Grand Rapids, Michigan
- The Cancer and Hematology Centers — Grand Rapids, Michigan
- Columbia University Medical Center - Herbert Irving Pavilion — New York, New York
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania
- Sarah Cannon Research Institute - Oncology Partners — Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Oncology Consultants, PA- Houston — Houston, Texas
- Next Oncology Dallas — Irving, Texas
- NEXT Oncology Virginia — Fairfax, Virginia
- Swedish Cancer Institute — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (855) 433-2246
Email: IDEAYAClinicalTrials@ideayabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Small-cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.