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

NCT07174583 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IDE849-001
• Study Type: interventional
• Target: 208
• Locations: 7 countries
• Sites: 39

Brief 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.

Conditions

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

Keywords

IDE849; Small Cell Lung Cancer; SCLC; anti-DLL3 immunoglobulin G1 monoclonal antibody; DLL3; Neuroendocrine Carcinomas; NEC; durvalumab; IDE161

Outcome Measures

Primary Outcomes (6)

• 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.

  approximately 4 years total study duration

• 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.

  approximately 4 years total study duration

• 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

  approximately 4 years total study duration

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

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

  approximately 4 years total study duration

• 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.

  approximately 4 years total study duration

• 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.

  approximately 4 years total study duration

Secondary Outcomes (6)

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

  approximately 4 years total study duration

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

  approximately 4 years total study duration

• Part 2: Overall Survival (OS)

  approximately 4 years total study duration

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

  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

  approximately 4 years total study duration

Study Arms (6)

Experimental: Part 1A IDE849 Monotherapy (Dose Escalation)

EXPERIMENTAL

Successive cohorts of participants will be treated with escalating doses of IDE849 until the maximum tolerated dose and dose for expansion are determined

Drug: IDE849

Experimental: Part 1B IDE849 + durvalumab (Dose Escalation)

EXPERIMENTAL

Multiple doses of IDE849 will be tested in combination with durvalumab to identify the optimal combination dose.

Drug: IDE849; Drug: durvalumab

Experimental: Part 1B IDE849 + IDE161 (Dose Escalation)

EXPERIMENTAL

Multiple doses of IDE849 will be tested in combination with IDE161 to identify the optimal combination dose.

Drug: IDE849; Drug: IDE161

Experimental: Part 2 IDE849 Monotherapy (Dose Expansion)

EXPERIMENTAL

Chosen monotherapy doses of IDE849 will be tested in additional participants.

Drug: IDE849

Experimental: Part 2 IDE849 + durvalumab (Dose Expansion)

EXPERIMENTAL

Chose combination dose of IDE849 + durvalumab will be tested in additional participants.

Drug: IDE849; Drug: durvalumab

Experimental: Part 2 IDE849 + IDE161 (Dose Expansion)

EXPERIMENTAL

Chose combination dose of IDE849 + IDE161 will be testing in additional participants

Drug: IDE849; Drug: IDE161

Interventions

durvalumab DRUG

IV administration

Also known as: durvalumab Injection [Imfinzi]

Experimental: Part 1B IDE849 + durvalumab (Dose Escalation); Experimental: Part 2 IDE849 + durvalumab (Dose Expansion)

IDE161 DRUG

oral administration

Experimental: Part 1B IDE849 + IDE161 (Dose Escalation); Experimental: Part 2 IDE849 + IDE161 (Dose Expansion)

IDE849 DRUG

IV administration

Experimental: Part 1A IDE849 Monotherapy (Dose Escalation); Experimental: Part 1B IDE849 + IDE161 (Dose Escalation); Experimental: Part 1B IDE849 + durvalumab (Dose Escalation); Experimental: Part 2 IDE849 + IDE161 (Dose Expansion); Experimental: Part 2 IDE849 + durvalumab (Dose Expansion); Experimental: Part 2 IDE849 Monotherapy (Dose Expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• Subjects will be required to provide blood/tumor tissue samples for biomarker testing.
• Have at least 1 measurable lesion according to 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.
• 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.

You may not qualify if:

• Have mixed SCLC and nonsmall cell lung cancer histology (SCLC with components of large cell neuroendocrine carcinoma are eligible).
• 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.
• 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.
• 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 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 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
• 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
• Administration of any of the following:
• Strong inhibitors or inducers of CYP3A4

Sponsors & Collaborators

• IDEAYA Biosciences: lead

Study Sites (39)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

Mayo Clinic Hospital - Florida

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

NOT YET RECRUITING

Piedmont Physicians Medical Oncology - Atlanta

Atlanta, Georgia, 30318, United States

NOT YET RECRUITING

The University of Chicago Medical Center - Duchossois Center for Advanced Medicine

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

OSF HealthCare Cancer Institute

Peoria, Illinois, 61637, United States

NOT YET RECRUITING

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

Fort Wayne, Indiana, 46825-1623, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Trinity Health-IHA Medical Group - Hematology Oncology - Ann Arbor Campus

Ann Arbor, Michigan, 48106, United States

NOT YET RECRUITING

The Cancer and Hematology Centers

Grand Rapids, Michigan, 49546, United States

RECRUITING

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032, United States

RECRUITING

Weill Cornell Medicine - Cutaneous Oncology and Melanoma Program

New York, New York, 10065, United States

NOT YET RECRUITING

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Sarah Cannon Research Institute - Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas MD Anderson Cancer Center Houston, Texas 77030-4000

Houston, Texas, 77030-4000, United States

NOT YET RECRUITING

Oncology Consultants, PA - Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

Next Oncology Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

NOT YET RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

NOT YET RECRUITING

Flinders Private Hospital - Southern Oncology Clinical Research Unit (SOCRU)

Bedford Park, South Australia, 5042, Australia

NOT YET RECRUITING

Cabrini Hospital - Malvern

Clayton, Victoria, 3168, Australia

NOT YET RECRUITING

Hospital de Câncer de Barretos - Fundação Pio XII

Barretos, São Paulo, 14784-400, Brazil

NOT YET RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, São Paulo, 90570-020, Brazil

NOT YET RECRUITING

Faculdade de Medicina de Sao Jose do Rio Preto-SP - Hospital de Base

São José do Rio Preto, São Paulo, 15090-000, Brazil

NOT YET RECRUITING

Next Brasil (Rede D'Or)

São Paulo, São Paulo, 04543-000, Brazil

NOT YET RECRUITING

University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)

Toronto, Ontario, M5G 2M9, Canada

NOT YET RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, Tokyo-To, 113-8677, Japan

NOT YET RECRUITING

National Cancer Center

Gyeonggi-do, Gyeonggi-do, 10408, South Korea

NOT YET RECRUITING

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 361-711, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

NOT YET RECRUITING

Severance Hospital - Yonsei Cancer Center

Seoul, Seoul, 120-749, South Korea

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

NOT YET RECRUITING

South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro

Madrid, Madrid, 28050, Spain

NOT YET RECRUITING

NEXT Madrid -Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

NOT YET RECRUITING

Hopsital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Neuroendocrine

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

IDEAYA Clinical Trials

CONTACT

+1-855-433-2246; IDEAYAClinicalTrials@ideayabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 16, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

AU (4); JP (1); US (20); ES (4); CA (2); KR (4); BR (4)