Actively Recruiting
A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IDE849, an anti-DLL3 antibody-drug conjugate, in patients with DLL3-expressing tumors such as small-cell lung cancer (SCLC), high-grade neuroendocrine carcinomas (NEC), and other DLL3-positive solid tumors. This Phase 1/2 multicenter, open-label study aims to assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of IDE849 alone and combined with durvalumab or IDE161. The study focuses on patients with extensive-stage disease who have progressed after standard treatments. During Part 1 (Dose Escalation), participants will receive escalating doses of IDE849 alone or combined with durvalumab or IDE161 to identify the maximum tolerated dose and the recommended dose for expansion. In Part 2 (Dose Expansion), selected doses of IDE849 as monotherapy or in combination will be further tested in defined patient cohorts. IDE849 and durvalumab are given by intravenous administration, while IDE161 is taken orally. Participants will undergo safety and tolerability assessments throughout approximately 4 years, including pharmacokinetic and immunogenicity testing. Researchers will measure tumor responses using RECIST 1.1 criteria and monitor progression-free and overall survival. Blood and tumor tissue samples will be collected for biomarker analysis. The study includes detailed monitoring for side effects and response to treatment during both dose escalation and expansion phases.
CONDITIONS
Brief 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 and able to participate and sign informed consent
- Histologically or cytologically confirmed extensive-stage small-cell lung cancer, high-grade neuroendocrine carcinoma, or other DLL3-positive tumors
- Radiologic progression after prior standard treatments including platinum-based therapy and immunotherapy (except if unsuitable or refused)
- No more than 2 prior lines of systemic chemotherapy and no more than 3 total lines of systemic therapy in recurrent or metastatic setting
- Provide blood and tumor samples for biomarker testing
- At least one measurable lesion by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy greater than 3 months
- Adequate bone marrow and organ function
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during and months after treatment
You will not qualify if you...
- Mixed small-cell lung cancer with nonsmall cell lung cancer histology (except SCLC with large cell neuroendocrine carcinoma)
- Untreated or active central nervous system tumor metastases
- Other malignancies within 2 years except certain treated cancers or with medical monitor approval
- Uncontrolled tumor-associated pain
- Severe cardiovascular or cerebrovascular disease
- Recent significant bleeding within 3 months
- History or current pneumonitis or serious lung diseases affecting breathing
- Immunodeficiency including positive HIV test
- Known or suspected viral hepatitis
- Active tuberculosis within 1 year
- For combination with durvalumab: prior severe immune-related adverse events
- For combination with IDE161: prior gastrectomy, bowel surgery, or gastrointestinal disorders affecting absorption
- Recent chemotherapy, immunotherapy, or investigational treatments within specified timeframes
- Use of certain strong enzyme inhibitors or inducers and drugs with QT prolongation risk
- Prior treatment with DLL3 antibody-drug conjugates or topoisomerase I inhibitors
- Prior intolerance to PD-1/PD-L1 inhibitors for durvalumab combination
- Recent high-dose chest or non-chest radiotherapy
- Major surgery or significant trauma within 4 weeks
- Pregnant, lactating, or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies by cohort until maximum tolerated dose or recommended dose for expansion is identified
Participants receive initial doses of IDE849 alone or in combination with durvalumab or IDE161 to assess safety and determine the optimal dose.
Multiple visits during dose escalation
Duration - Up to approximately 4 years total study duration
Participants receive IDE849 alone or in combination at selected dose levels to evaluate safety, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity.
Regular visits as per treatment schedule
Duration - Up to approximately 4 years total study duration
Participants are monitored for safety, response to treatment, and survival outcomes after completing treatment.
Visits scheduled according to follow-up assessments
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
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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