NCT07174583 · IDEAYA Biosciences
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
What this study is about
This is Phase 1/2, conducted at multiple hospitals, clinical study to evaluate the safety, effectiveness, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
View original scientific description
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.
Interventions
DRUG
IDE849
IV administration
DRUG
durvalumab
IV administration
DRUG
IDE161
oral administration
DRUG
Carboplatin
IV administration
Primary outcome measures
Part 1A: Safety and Tolerability of IDE849 (Monotherapy)
Time frame: 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 IDE161
Time frame: approximately 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)
Time frame: 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)
Time frame: 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 1.1
Time frame: approximately 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 1.1
Time frame: approximately 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 SCLC who have radiologically progressed or recurred after previous standard treatment, including 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
Where
- Denver, Colorado
- Orlando, Florida
- Fort Wayne, Indiana
- Grand Rapids, Michigan
- New York, New York
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
- Irving, Texas
- Fairfax, Virginia
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations