RecruitingPhase 1Phase 2NCT07174583

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including Small Cell Lung Cancer

Sponsor

IDEAYA Biosciences

Enrollment

208 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer Neuroendocrine Carcinomas Solid Tumor Show to Express DLL3

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called IDE849 for people with certain types of cancer that carry a protein called DLL3 — including small cell lung cancer and other neuroendocrine tumors. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer (SCLC), neuroendocrine carcinoma, or another tumor confirmed to express DLL3 - Your cancer has come back or gotten worse after standard treatment (such as platinum-based chemotherapy and immunotherapy) - You are willing and able to follow the study procedures and sign a consent form **You may NOT be eligible if...** - Your cancer has not been previously treated with standard therapies - You have certain other health conditions that the study team determines make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIDE849

IV administration

DRUGdurvalumab

IV administration

DRUGIDE161

oral administration

Locations(39)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Mayo Clinic Hospital - Florida

Jacksonville, Florida, United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States

Piedmont Physicians Medical Oncology - Atlanta

Atlanta, Georgia, United States

The University of Chicago Medical Center - Duchossois Center for Advanced Medicine

Chicago, Illinois, United States

OSF HealthCare Cancer Institute

Peoria, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne North Office

Fort Wayne, Indiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Trinity Health-IHA Medical Group - Hematology Oncology - Ann Arbor Campus

Ann Arbor, Michigan, United States

The Cancer and Hematology Centers

Grand Rapids, Michigan, United States

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, United States

Weill Cornell Medicine - Cutaneous Oncology and Melanoma Program

New York, New York, United States

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute - Oncology Partners

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center Houston, Texas 77030-4000

Houston, Texas, United States

Oncology Consultants, PA - Houston

Houston, Texas, United States

Next Oncology Dallas

Irving, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Private Hospital - Southern Oncology Clinical Research Unit (SOCRU)

Bedford Park, South Australia, Australia

Cabrini Hospital - Malvern

Clayton, Victoria, Australia

Hospital de Câncer de Barretos - Fundação Pio XII

Barretos, São Paulo, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, São Paulo, Brazil

Faculdade de Medicina de Sao Jose do Rio Preto-SP - Hospital de Base

São José do Rio Preto, São Paulo, Brazil

Next Brasil (Rede D'Or)

São Paulo, São Paulo, Brazil

University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, Tokyo-To, Japan

National Cancer Center

Gyeonggi-do, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, Seoul, South Korea

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro

Madrid, Madrid, Spain

NEXT Madrid -Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hopsital Universitario Virgen Macarena

Seville, Sevilla, Spain

View Full Details on ClinicalTrials.gov

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