RECRUITING

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

Conditions

Small-cell Lung Cancer IDE849 Small Cell Lung Cancer SCLC anti-DLL3 immunoglobulin G1 monoclonal antibody DLL3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09

Study Completion:2029-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07174583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 8. Women of childbearing potential must agree to take highly effective contraceptive measures.	1. Have mixed SCLC and nonsmall cell lung cancer histology (SCLC with components of large cell neuroendocrine carcinoma are eligible). 2. Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis. 3. Have severe cardiovascular and cerebrovascular disease. 4. Have history of clinically significant bleeding within 3 months before the first study dose. 5. 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. 6. Have history of severe infections within 4 weeks prior to the start of study treatment. 7. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test. 8. Subjects with known or suspected viral hepatitis. 9. Have a history of active tuberculosis within 1 year before enrollment. 10. Have received chemotherapy within 4 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 shorter); other investigational products within 4 weeks or within 5 half-lives of the drug (whichever is shorter). 11. Administration of any of the following within 2 weeks before the first dose of the IMP or within 5 half-lives of the drug (whichever is shorter): Strong inhibitors or inducers of CYP3A4, Strong inhibitors of CYP2D6, Strong inhibitors of P-gp and BCRP. 12. Have prior treatment with DLL3 ADC or prior treatment with a topoisomerase I inhibitor including an ADC with a topoisomerase I inhibitor payload. 13. Have received \> 30 Gy of chest radiotherapy within 12 weeks prior to the first dose of the IMP, \> 30 Gy of nonchest radiotherapy within 4 weeks 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). 14. Have undergone major surgery (excluding aspiration or core biopsy) or experienced significant trauma within 4 weeks prior to the first dose. 15. 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.

Inclusion Criteria

Exclusion Criteria

1. 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.
8. Women of childbearing potential must agree to take highly effective contraceptive measures.

1. Have mixed SCLC and nonsmall cell lung cancer histology (SCLC with components of large cell neuroendocrine carcinoma are eligible).
2. Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.
3. Have severe cardiovascular and cerebrovascular disease.
4. Have history of clinically significant bleeding within 3 months before the first study dose.
5. 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.
6. Have history of severe infections within 4 weeks prior to the start of study treatment.
7. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test.
8. Subjects with known or suspected viral hepatitis.
9. Have a history of active tuberculosis within 1 year before enrollment.
10. Have received chemotherapy within 4 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 shorter); other investigational products within 4 weeks or within 5 half-lives of the drug (whichever is shorter).
11. Administration of any of the following within 2 weeks before the first dose of the IMP or within 5 half-lives of the drug (whichever is shorter): Strong inhibitors or inducers of CYP3A4, Strong inhibitors of CYP2D6, Strong inhibitors of P-gp and BCRP.
12. Have prior treatment with DLL3 ADC or prior treatment with a topoisomerase I inhibitor including an ADC with a topoisomerase I inhibitor payload.
13. Have received \> 30 Gy of chest radiotherapy within 12 weeks prior to the first dose of the IMP, \> 30 Gy of nonchest radiotherapy within 4 weeks 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).
14. Have undergone major surgery (excluding aspiration or core biopsy) or experienced significant trauma within 4 weeks prior to the first dose.
15. 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.

Contacts and Locations

Study Contact

IDEAYA Clinical Trials

CONTACT

+1 650-534-3616

IDEAYAClinicalTrials@ideayabio.com

Study Locations (Sites)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

United States

The Cancer and Hematology Centers

Grand Rapids, Michigan, 49546

United States

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032

United States

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Sarah Cannon Research Institute - Oncology Partners

Nashville, Tennessee, 37203

United States

MD Anderson

Houston, Texas, 77030

United States

Next Oncology Dallas

Irving, Texas, 75039

United States

NEXT Oncology Virginia

Fairfax, Virginia, 22031

United States

Swedish Cancer Institute

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: IDEAYA Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09

Study Completion Date2029-05

Study Record Updates

Study Start Date2025-09

Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

IDE849
Small Cell Lung Cancer
SCLC
anti-DLL3 immunoglobulin G1 monoclonal antibody
DLL3

Additional Relevant MeSH Terms

Small-cell Lung Cancer