A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
NCT ID: NCT07174583
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
208 participants
INTERVENTIONAL
2025-10-14
2029-05-31
Brief Summary
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Detailed Description
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Part 1 (Dose Escalation):
Part 1A will evaluate IDE849 monotherapy, and Part 1B will evaluate IDE849 in combination with durvalumab or IDE161. This phase is designed to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE), in subjects with extensive-stage SCLC, high-grade NEC, or other DLL3-expressing tumors.
Part 2 (Dose Expansion):
Part 2 further will evaluate IDE849 alone or in combination at selected dose levels to characterize safety, PK, immunogenicity, and preliminary anti-tumor activity in defined cohorts of subjects with extensive-stage SCLC, high-grade NEC, or other DLL3-expressing tumors.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Part 1A IDE849 Monotherapy (Dose Escalation)
Successive cohorts of participants will be treated with escalating doses of IDE849 until the maximum tolerated dose and dose for expansion are determined
IDE849
IV administration
Experimental: Part 1B IDE849 + durvalumab (Dose Escalation)
Multiple doses of IDE849 will be tested in combination with durvalumab to identify the optimal combination dose.
IDE849
IV administration
durvalumab
IV administration
Experimental: Part 1B IDE849 + IDE161 (Dose Escalation)
Multiple doses of IDE849 will be tested in combination with IDE161 to identify the optimal combination dose.
IDE849
IV administration
IDE161
oral administration
Experimental: Part 2 IDE849 Monotherapy (Dose Expansion)
Chosen monotherapy doses of IDE849 will be tested in additional participants.
IDE849
IV administration
Experimental: Part 2 IDE849 + durvalumab (Dose Expansion)
Chose combination dose of IDE849 + durvalumab will be tested in additional participants.
IDE849
IV administration
durvalumab
IV administration
Experimental: Part 2 IDE849 + IDE161 (Dose Expansion)
Chose combination dose of IDE849 + IDE161 will be testing in additional participants
IDE849
IV administration
IDE161
oral administration
Interventions
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IDE849
IV administration
durvalumab
IV administration
IDE161
oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with histologically or cytologically confirmed extensive-stage SCLC neuroendocrine carcinoma (NEC), and other DLL3+ tumors, are eligible per protocol. Subjects must have radiologically progressed or recurred after previous standard treatment, For SCLC, this includes platinum-based therapy and programmed death-1/programmed death-ligand 1 inhibitors (except for subjects who refuse or are judged by the Investigator to be unsuitable for immunotherapy). No more than 2 lines of previous systemic chemotherapy in any setting and no more than 3 total lines of systemic therapy in the recurrent or metastatic setting will be allowed.
3. Subjects will be required to provide blood/tumor tissue samples for biomarker testing.
4. Have at least 1 measurable lesion according to RECIST version 1.1.
5. Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
6. Have life expectancy \> 3 months.
7. Have adequate bone marrow and organ function.
8. Women of childbearing potential must agree to take highly effective contraceptive measures from signing of consent through 8 months after the last dose of IDE849; men with partners of child-bearing potential must use effective contraception through 5 months after the last dose.
Exclusion Criteria
2. Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.
3. 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.
4. Have uncontrolled tumor-associated pain.
5. Have severe cardiovascular and cerebrovascular disease
6. Have history of clinically significant bleeding within 3 months before the first study dose.
7. 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.
8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test.
9. Subjects with known or suspected viral hepatitis.
10. Have a history of active tuberculosis within 1 year before enrollment.
11. For participants enrolling to receive the combination with durvalumab, must not 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
12. For participants enrolling to receive the combination with IDE161, must not have had prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect eg, malabsorption disorder such as Crohn's disease or ulcerative colitis, that would interfere with absorption of IDE161
13. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted anti-tumor treatments within 2 weeks before the first dose of IMP; for small molecule treatments within 2 weeks before the first dose of the IMP or within 5 half lives of the drug (whichever is longer); other investigational products within 4 weeks or within 5 half-lives of the drug (whichever is longer) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Participants who received an immunotherapy agent (eg, PD-1/PD-L1 inhibitor) immediately prior to study enrollment must have documented radiologic disease progression as per the Investigator prior to first dose of IMP
14. Administration of any of the following:
* Strong inhibitors or inducers of CYP3A4
* Strong inhibitors of CYP2D6
* Strong inhibitors of P-gp or BCRP
* Use of drugs with a known risk of QT prolongation
15. For participants enrolling to receive the combination with IDE161:
* Use of drugs of narrow therapeutic index that are sensitive substrates of MATE2-K, BCRP, and P-gp
* Use of known moderate and strong CYP3A4/5 inducers and inhibitors is not permitted
* Administration of PPIs
* Use of an H2 blocking agent
* Use of a local antacid
* Use of drugs with a known risk of QT prolongation
16. Have prior treatment with DLL3 ADC or prior treatment with a topoisomerase I inhibitor including an ADC with a topoisomerase I inhibitor payload.
17. For participants enrolling to receive the combination with durvalumab, have history of prior intolerance to PD-1/PD-L1 inhibitors
18. Have received \> 30 Gy of chest radiotherapy within 12 weeks prior to the first dose of the IMP, \> 30 Gy of non-chest radiotherapy within 4 weeks prior to the first dose (subjects who have completed radiotherapy for brain metastases within 14 days prior to the first dose can be enrolled and palliative radiotherapy for other sites of ≤ 30 Gy is allowed if completed more than 14 days prior to the first dose).
19. Have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose.
20. Female subjects who are pregnant, lactating, or planning to become pregnant during the study period to 8 months after the last dose of the IMP.
18 Years
ALL
No
Sponsors
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IDEAYA Biosciences
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: backup
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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IDE849-001
Identifier Type: -
Identifier Source: org_study_id
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