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

Part of paid clinical trials in Denver, Colorado.

Sponsor
IDEAYA Biosciences
Study ID
NCT07174583
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IDE849 — DRUG
    IV administration
  • durvalumab — DRUG
    IV administration
  • IDE161 — DRUG
    oral administration
  • Carboplatin — DRUG
    IV administration

Study Details

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.

Key Dates

First listed
Sep 16, 2025
Start date
Oct 14, 2025
Status verified
Jul 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
262 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Experimental: Part 1B IDE849 + durvalumab, or IDE849 + durvalumab + carboplatin (Dose Escalation)
    Multiple doses of IDE849 will be tested in combination with durvalumab or in combination with durvalumab + carboplatin to identify the optimal combination dose.
  • Experimental: Part 1B IDE849 + IDE161 (Dose Escalation)
    Multiple doses of IDE849 will be tested in combination with IDE161 to identify the optimal combination dose.
  • Experimental: Part 2 IDE849 Monotherapy RDE 1 for SCLC (Dose Expansion)
    Chosen monotherapy doses of IDE849 will be tested in additional participants.
  • Experimental: Part 2 IDE849 Monotherapy RDE 2 for SCLC (Dose Expansion)
    Chosen monotherapy doses of IDE849 will be tested in additional participants
  • Experimental: Part 2 IDE849 Monotherapy for NEC (Dose Expansion)
    Chosen monotherapy doses of IDE849 will be tested in additional participants.
  • Experimental: Part 2 IDE849 + durvalumab (Dose Expansion)
    Chosen combination dose of IDE849 + durvalumab will be tested in additional participants.
  • Experimental: Part 2 IDE849 + durvalumab + carboplatin (Dose Expansion)
    Chosen combination dose of IDE849 + durvalumab + carboplatin will be tested in additional participants.
  • Experimental: Part 2 IDE849 + IDE161 (Dose Expansion)
    Chosen combination dose of IDE849 + IDE161 will be testing in additional participants

Primary Outcome Measure

Part 1A: Safety and Tolerability of IDE849 (Monotherapy) [ Time Frame: approximately 4 years total study duration ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827-
Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne North OfficeFort WayneIndiana46825-1623-
START MidwestGrand RapidsMichigan49546-
The Cancer and Hematology CentersGrand RapidsMichigan49546-
Columbia University Medical Center - Herbert Irving PavilionNew YorkNew York10032-
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Sarah Cannon Research Institute - Oncology PartnersNashvilleTennessee37203-
Oncology Consultants, PA- HoustonHoustonTexas77030-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4000-
Next Oncology DallasIrvingTexas75039-
NEXT Oncology VirginiaFairfaxVirginia22031-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Denver, CO

By research site
Sarah Cannon Research Institute at HealthONE· Denver, COSarah Cannon Research Institute at Florida Cancer Specialists· Orlando, FLFort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne North Office· Fort Wayne, INSTART Midwest· Grand Rapids, MIThe Cancer and Hematology Centers· Grand Rapids, MIColumbia University Medical Center - Herbert Irving Pavilion· New York, NY

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