A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (NCT07174583) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
United States262 participantsStarted 2025-10-14
Plain-language summary
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 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
. Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.
. Subjects with histologically or cytologically confirmed ES- SCLC, neuroendocrine carcinoma (NEC), DLL3+ solid tumors, are eligible per protocol. Subjects must have radiologically progressed or recurred after previous standard treatment.
. Subjects with NEC, this includes
. Subjects with other solid tumors demonstrated to express moderate/high expression of DLL3 including metastatic melanoma, Grade 3 gastrointestinal and pancreatic NETs, and pulmonary carcinoids.
. Subjects will be required to provide blood/tumor tissue samples for biomarker testing.
. Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
. Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
. Have life expectancy \> 3 months.
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.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Part 1A: Safety and Tolerability of IDE849 (Monotherapy)
Timeframe: approximately 4 years total study duration
2
Part 1B: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161
Timeframe: approximately 4 years total study duration
3
Part 2: Safety and Tolerability of IDE849 (Monotherapy Dose Expansion)
Timeframe: approximately 4 years total study duration
4
Part 2: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161 or durvalumab + carboplatin (Dose Expansion)
Timeframe: approximately 4 years total study duration
5
Part 2: Objective Response Rate (ORR) and Investigator Assessment of IDE849 ORR per RECIST 1.1
Timeframe: approximately 4 years total study duration
6
Part 2: Duration of Response (DOR) and Investigator Assessment of IDE849 DOR per RECIST 1.1
Timeframe: approximately 4 years total study duration
. 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).