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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (NCT07174583) is a Phase 1 / Phase 2 interventional studying Small-cell Lung Cancer and Neuroendocrine Carcinomas, sponsored by IDEAYA Biosciences. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Small-cell Lung Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 208 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Small-cell Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF. 2. Subjects with diagnosed by tissue sample (biopsy-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. Who Should NOT Join This Trial: 1. Have mixed SCLC and nonsmall cell lung cancer histology (SCLC with components of large cell neuroendocrine carcinoma are eligible). 2. Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF. 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: 1. Have mixed SCLC and nonsmall cell lung cancer histology (SCLC with components of large cell neuroendocrine carcinoma are eligible). 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.

Treatments Being Tested

DRUG

IDE849

IV administration

DRUG

durvalumab

IV administration

DRUG

IDE161

oral administration

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07174583), the sponsor (IDEAYA Biosciences), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07174583 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07174583?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07174583?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07174583. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07174583. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.