Actively Recruiting
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
Led by IDEAYA Biosciences · Updated on 2026-01-23
208
Participants Needed
39
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate in the study, understand the procedures, and able to sign consent
- Have confirmed extensive-stage small-cell lung cancer (SCLC), high-grade neuroendocrine carcinoma (NEC), or other DLL3-positive tumors
- Have disease that has progressed or recurred after standard treatment including platinum-based chemotherapy and immunotherapy for SCLC
- Have had no more than 2 prior lines of systemic chemotherapy and no more than 3 total lines of systemic therapy for recurrent or metastatic disease
- Able to provide blood and tumor tissue samples for biomarker testing
- Have at least one measurable tumor lesion by RECIST version 1.1
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have a life expectancy greater than 3 months
- Have adequate bone marrow and organ function
- Women of childbearing potential must agree to use highly effective contraception during and for 8 months after treatment; men with partners of childbearing potential must use effective contraception during and for 5 months after treatment
You will not qualify if you...
- Have mixed small-cell lung cancer and nonsmall cell lung cancer histology (except SCLC with large cell neuroendocrine carcinoma components)
- Have untreated or active central nervous system tumor metastases
- Have had other cancers within 2 years before the first dose, except some treated cancers such as carcinoma in situ, certain skin cancers, localized prostate cancer, or papillary thyroid cancer
- Have uncontrolled tumor-associated pain
- Have severe heart or cerebrovascular disease
- Have had clinically significant bleeding within 3 months before first study dose
- Have history or current noninfectious pneumonitis or serious lung diseases affecting breathing within 3 months before first dose
- Have immunodeficiency including positive HIV test
- Have known or suspected viral hepatitis
- Have had active tuberculosis within 1 year before enrolling
- For combination with durvalumab, have prior severe immune-related adverse events or myocarditis
- For combination with IDE161, have had gastrectomy, bowel removal, or gastrointestinal disorders affecting drug absorption
- Have received chemotherapy, immunotherapy, or investigational drugs within specified washout periods before first dose
- Use of certain medications affecting drug metabolism or with QT prolongation risk
- Prior treatment with DLL3 antibody-drug conjugates or topoisomerase I inhibitors
- History of intolerance to PD-1/PD-L1 inhibitors for durvalumab combination
- Recent high-dose chest or other radiotherapy within specified time frames
- Recent major surgery or significant trauma within 4 weeks before first dose
- Pregnant or breastfeeding women or planning pregnancy during study and 8 months after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
2
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
3
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States, 32827
Not Yet Recruiting
4
Piedmont Physicians Medical Oncology - Atlanta
Atlanta, Georgia, United States, 30318
Not Yet Recruiting
5
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, United States, 60637
Not Yet Recruiting
6
OSF HealthCare Cancer Institute
Peoria, Illinois, United States, 61637
Not Yet Recruiting
7
Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne North Office
Fort Wayne, Indiana, United States, 46825-1623
Not Yet Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
9
Trinity Health-IHA Medical Group - Hematology Oncology - Ann Arbor Campus
Ann Arbor, Michigan, United States, 48106
Not Yet Recruiting
10
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
11
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States, 10032
Actively Recruiting
12
Weill Cornell Medicine - Cutaneous Oncology and Melanoma Program
New York, New York, United States, 10065
Not Yet Recruiting
13
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
14
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
The University of Texas MD Anderson Cancer Center Houston, Texas 77030-4000
Houston, Texas, United States, 77030-4000
Not Yet Recruiting
16
Oncology Consultants, PA - Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
17
Next Oncology Dallas
Irving, Texas, United States, 75039
Actively Recruiting
18
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
19
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
20
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Not Yet Recruiting
21
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Not Yet Recruiting
22
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Not Yet Recruiting
23
Flinders Private Hospital - Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia, 5042
Not Yet Recruiting
24
Cabrini Hospital - Malvern
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
25
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, São Paulo, Brazil, 14784-400
Not Yet Recruiting
26
Hospital de Clínicas de Porto Alegre
Porto Alegre, São Paulo, Brazil, 90570-020
Not Yet Recruiting
27
Faculdade de Medicina de Sao Jose do Rio Preto-SP - Hospital de Base
São José do Rio Preto, São Paulo, Brazil, 15090-000
Not Yet Recruiting
28
Next Brasil (Rede D'Or)
São Paulo, São Paulo, Brazil, 04543-000
Not Yet Recruiting
29
University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
30
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
31
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, Tokyo-To, Japan, 113-8677
Not Yet Recruiting
32
National Cancer Center
Gyeonggi-do, Gyeonggi-do, South Korea, 10408
Not Yet Recruiting
33
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea, 361-711
Not Yet Recruiting
34
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Not Yet Recruiting
35
Severance Hospital - Yonsei Cancer Center
Seoul, Seoul, South Korea, 120-749
Not Yet Recruiting
36
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Not Yet Recruiting
37
South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro
Madrid, Madrid, Spain, 28050
Not Yet Recruiting
38
NEXT Madrid -Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Not Yet Recruiting
39
Hopsital Universitario Virgen Macarena
Seville, Sevilla, Spain, 41009
Not Yet Recruiting
Research Team
I
IDEAYA Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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