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Small-cell Lung CancerPhase 1/2NCT07174583

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

A Phase 1/2 study testing IDE849, durvalumab and IDE161 in people with Small-cell Lung Cancer and Neuroendocrine Carcinomas, run by IDEAYA Biosciences at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IDE849, durvalumab and IDE161
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
13 sitesUnited States
Study dates
14 Oct 2025to Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.
  • Subjects with histologically or cytologically confirmed ES- SCLC, neuroendocrine carcinoma (NEC), DLL3+ solid 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, or were intolerant to immunotherapy and chemotherapy may enroll to receive monotherapy or IDE161 combination.
  • Subjects with NEC, this includes
  • High-grade gastroenteropancreatic NEC
  • NEC of the prostate
Show all 18Show fewer
  • Small cell NEC of any other organ
  • Merkel cell carcinoma
  • Transformed non-small cell adenocarcinoma of the lung (including but not limited to epidermal growth factor receptor or Kirsten rat sarcoma viral oncogene homolog mutated adenocarcinoma of the lung post progression on targeted therapies
  • Any other NEC that does not meet any of the indications noted above.
  • Subjects with other solid tumors demonstrated to express moderate/high expression of DLL3 including metastatic melanoma, Grade 3 gastrointestinal and pancreatic NETs, and pulmonary carcinoids.
  • metastatic melanoma
  • Subjects will be required to provide blood/tumor tissue samples for biomarker testing.
  • Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
  • Have life expectancy > 3 months.
  • Have adequate bone marrow and organ function within 7 days of the first dose (no use of any blood components and/or cell growth factors within 14 days prior to the start of the study treatment).
  • Women of childbearing potential (WOCBP) 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 cannot join

  • Have mixed SCLC and NSCLC histology are not allowed (SCLC with components of large cell NEC are eligible). Participants with limited stage SCLC are ineligible.
  • Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.
  • 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.
  • Have uncontrolled tumor-associated pain.
  • Have severe cardiovascular and cerebrovascular disease
  • Have history of clinically significant bleeding within 3 months before the first study dose.
Show all 29Show fewer
  • 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.
  • Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening (HIV antibody positive and HIV-RNA above the lower limit of detection of the analytical method).
  • Subjects with known or suspected viral hepatitis.
  • Have a history of active tuberculosis within 1 year before enrollment.
  • For participants enrolling to receive the combination with durvalumab, must not be deemed by the Investigator to be unsuitable to receive immunotherapy, or have had any prior intolerance to PD-1/PD-L1 inhibitor therapy, or 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.
  • For participants enrolling to receive the combination with IDE161, must not have had prior GI 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.
  • For patients receiving a combination with carboplatin, be deemed by the Investigator to be unsuitable to receive platinum-based chemotherapy, or have had intolerance to platinum-based chemotherapy
  • Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor 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 the first dose of IMP
  • Administration of any of the following:
  • Use of drugs that are inhibitors of P-gp, BCRP, and OATPIB1/OATP1B3
  • Use of drugs with known risk of QT prolongation within 5 half-lives of their administration.
  • 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
  • Have prior treatment with DLL3 ADC with a Topo1 inhibitor payload (except for participants enrolling to receive the IDE161 combination).
  • For participants enrolling to receive the combination with durvalumab, have history of prior intolerance to PD-1/PD-L1 inhibitors.
  • Have received > 30 Gy of chest radiotherapy within 8 weeks prior to the first dose of the IMP, > 30 Gy of non-chest radiotherapy within 14 days 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).
  • Have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose.
  • 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.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

IDEAYA Clinical Trials contact

+1-855-433-2246

IDEAYAClinicalTrials@ideayabio.com

13 sites in 1 country

United States13 sites, 13 recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

    Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031

    Recruiting

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

    Fort Wayne, Indiana, 46825-1623

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan, 49546

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4000

    Recruiting

  • Oncology Consultants, PA- Houston

    Houston, Texas, 77030

    Recruiting

  • Next Oncology Dallas

    Irving, Texas, 75039

    Recruiting

  • Sarah Cannon Research Institute - Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York, 10032

    Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

    Recruiting

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

This multicenter, open-label, Phase 1/2 study is designed to further characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of IDE849, an anti-DLL3 antibody-drug conjugate, alone and in combination with durvalumab or IDE161, in subjects with DLL3-expressing tumors including small-cell lung cancer (SCLC), high-grade neuroendocrine carcinomas (NEC), and other DLL3-positive solid tumors.

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.

Being tested
IDE849, durvalumab, IDE161, Carboplatin
Keywords
IDE849, Small Cell Lung Cancer, SCLC, anti-DLL3 immunoglobulin G1 monoclonal antibody, DLL3, Neuroendocrine Carcinomas, NEC, durvalumab, IDE161
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDE849Drug

    IV administration

  • durvalumabDrug

    Also called durvalumab Injection [Imfinzi]

    IV administration

  • IDE161Drug

    oral administration

  • CarboplatinDrug

    IV administration

Study groups in NCT07174583
Study groupRoleWhat they receive
Part 1A IDE849 Monotherapy (Dose Escalation)ExperimentalSuccessive cohorts of participants will be treated with escalating doses of IDE849 until the maximum tolerated dose and dose for expansion are determined
Receives: Drug: IDE849
Part 1B IDE849 + durvalumab, or IDE849 + durvalumab + carboplatin (Dose Escalation)ExperimentalMultiple doses of IDE849 will be tested in combination with durvalumab or in combination with durvalumab + carboplatin to identify the optimal combination dose.
Receives: Drug: IDE849; Drug: durvalumab; Drug: Carboplatin
Part 1B IDE849 + IDE161 (Dose Escalation)ExperimentalMultiple doses of IDE849 will be tested in combination with IDE161 to identify the optimal combination dose.
Receives: Drug: IDE849; Drug: IDE161
Part 2 IDE849 Monotherapy RDE 1 for SCLC (Dose Expansion)ExperimentalChosen monotherapy doses of IDE849 will be tested in additional participants.
Receives: Drug: IDE849
Part 2 IDE849 Monotherapy RDE 2 for SCLC (Dose Expansion)ExperimentalChosen monotherapy doses of IDE849 will be tested in additional participants
Receives: Drug: IDE849
Part 2 IDE849 Monotherapy for NEC (Dose Expansion)ExperimentalChosen monotherapy doses of IDE849 will be tested in additional participants.
Receives: Drug: IDE849
Part 2 IDE849 + durvalumab (Dose Expansion)ExperimentalChosen combination dose of IDE849 + durvalumab will be tested in additional participants.
Receives: Drug: IDE849; Drug: durvalumab
Part 2 IDE849 + durvalumab + carboplatin (Dose Expansion)ExperimentalChosen combination dose of IDE849 + durvalumab + carboplatin will be tested in additional participants.
Receives: Drug: IDE849; Drug: durvalumab; Drug: Carboplatin
Part 2 IDE849 + IDE161 (Dose Expansion)ExperimentalChosen combination dose of IDE849 + IDE161 will be testing in additional participants
Receives: Drug: IDE849; Drug: IDE161

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1A: Safety and Tolerability of IDE849 (Monotherapy)

    Incidence of dose-limiting toxicities, incidence and severity AEs and SAEs as measured by CTCAE V5.0.

    Measured: approximately 4 years total study duration

  2. Part 1B: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161

    Incidence of dose-limiting toxicities, incidence and severity AEs and SAEs as measured by CTCAE V5.0.

    Measured: approximately 4 years total study duration

  3. Part 2: Safety and Tolerability of IDE849 (Monotherapy Dose Expansion)

    Incidence and severity and relationship of AEs and SAEs as measured by CTCAE V5.0

    Measured: approximately 4 years total study duration

  4. Part 2: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161 or durvalumab + carboplatin (Dose Expansion)

    Incidence and severity and relationship of AEs and SAEs graded as measured by CTCAE V 5.0.

    Measured: approximately 4 years total study duration

  5. Part 2: Objective Response Rate (ORR) and Investigator Assessment of IDE849 ORR per RECIST 1.1

    ORR per RECIST v1.1, defined as the proportion of subjects with a Complete Response (CR) or Partial Response (PR) as assessed by the Investigator.

    Measured: approximately 4 years total study duration

  6. Part 2: Duration of Response (DOR) and Investigator Assessment of IDE849 DOR per RECIST 1.1

    DOR per RECIST v1.1, defined as the time from the first documented Complete Response (CR) or Partial Response (PR) to disease progression or death, whichever occurs first, as assessed by the Investigator.

    Measured: approximately 4 years total study duration

Secondary outcomes (6)

  1. Part 1 and Part 2: Disease Control Rate (DCR) and Investigator Assessment of IDE849 DCR per RECIST 1.

    Measured: approximately 4 years total study duration

  2. Part 2: Progression-Free Survival (PFS) PFS per RECIST1.1 PFS per RECIST1.1.

    Measured: approximately 4 years total study duration

  3. Part 2: Overall Survival (OS)

    Overall Survival (OS) defined as the time from first dose of IDE849 to death due to any cause

    Measured: approximately 4 years total study duration

  4. Part 1 and Part 2: Pharmacokinetics (PK) of IDE849 and in combination with durvalumab, durvalumab + carboplatin, and IDE161 Blood concentrations and PK parameters.

    Measured: approximately 4 years total study duration

  5. Part 1 and Part 2: Dose-Exposure Response of IDE849 and in combination with durvalumab, durvalumab + carboplatin, and IDE161 Relationship between IDE849 dose level and systemic exposure based on plasma concentration data and pharmacokinetic parameters

    Measured: approximately 4 years total study duration

  6. Part 1 and Part 2: Dose-Exposure Response of IDE849 and in combination with durvalumab and IDE161 Relationship between IDE849 dose level and systemic exposure based on plasma concentration data and pharmacokinetic parameters

    Measured: approximately 4 years total study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start14 Oct 2025
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174583
Sponsor's protocol ID
IDE849-001
Status last verified
Jul 2026
First submitted
11 Sep 2025
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IDE849, durvalumab and IDE161 in people with Small-cell Lung Cancer and Neuroendocrine Carcinomas, run by IDEAYA Biosciences at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact IDEAYA Clinical Trials (+1-855-433-2246, IDEAYAClinicalTrials@ideayabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1A: Safety and Tolerability of IDE849 (Monotherapy) (time frame: approximately 4 years total study duration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07174583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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