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A Study of IDE849 for DLL3-Expressing Cancers

This study is testing a drug called IDE849, alone or with other drugs like durvalumab or IDE161, for people with certain cancers that have a specific marker called DLL3. These cancers include small cell lung cancer (SCLC), neuroendocrine carcinomas, and other solid tumors that express DLL3. The main goal is to see how safe IDE849 is and what side effects it might cause. Researchers will also look at how well the drug works against the cancer. You might be able to join if you are 18 or older, have one of these cancers, and your cancer has progressed or come back after standard treatments. The study is currently unclear about its recruitment status and plans to enroll 262 participants.

Study design
This is a Phase 1/2, multicenter, open-label study. It will involve 262 participants and test IDE849 alone and in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The safety and tolerability of the treatments will be measured for approximately 4 years total study duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07174583

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
IDEAYA Biosciences
~262 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:IDE849durvalumabIDE161Carboplatin

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1A: Safety and Tolerability of IDE849 (Monotherapy)
Measured over approximately 4 years total study duration
+5 more outcomes measured

Conditions

Small-cell Lung Cancer
Neuroendocrine Carcinomas
Solid Tumor Show to Express DLL3

Explore related trials

Digestive System Neuroendocrine TumorLung Neuroendocrine TumorLung Small Cell CarcinomaMelanomaNeuroendocrine CarcinomaPancreatic Neuroendocrine TumorSolid Neoplasm

Where it's being run

13 sites across 10 states
Texas3
Michigan2
Colorado1
Florida1
Indiana1
New York1
Pennsylvania1
Tennessee1

Who to contact

IDEAYA Clinical Trials
[email protected]
+1-855-433-2246
Email the study team

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Eligibility criteria

Inclusion

High-grade gastroenteropancreatic NEC
NEC of the prostate
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. 4. 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.

Exclusion

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. 16. 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 17. Have prior treatment with DLL3 ADC with a Topo1 inhibitor payload (except for participants enrolling to receive the IDE161 combination). 18. For participants enrolling to receive the combination with durvalumab, have history of prior intolerance to PD-1/PD-L1 inhibitors. 19. 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). 20. Have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose. 21. 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.

What this trial measures

  • Part 1A: Safety and Tolerability of IDE849 (Monotherapy)approximately 4 years total study duration

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

  • Part 1B: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161approximately 4 years total study duration

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

  • Part 2: Safety and Tolerability of IDE849 (Monotherapy Dose Expansion)approximately 4 years total study duration

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

  • Part 2: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161 or durvalumab + carboplatin (Dose Expansion)approximately 4 years total study duration

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

  • Part 2: Objective Response Rate (ORR) and Investigator Assessment of IDE849 ORR per RECIST 1.1approximately 4 years total study duration

    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.

  • Part 2: Duration of Response (DOR) and Investigator Assessment of IDE849 DOR per RECIST 1.1approximately 4 years total study duration

    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.