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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Florida
Sarah Cannon Research Institute at Florida Cancer Specialists
NOT_YET_RECRUITING
Orlando
Illinois
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
NOT_YET_RECRUITING
Chicago
Indiana
Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne North Office
NOT_YET_RECRUITING
Fort Wayne
Michigan
The Cancer and Hematology Centers
RECRUITING
Grand Rapids
New York
Columbia University Medical Center - Herbert Irving Pavilion
NOT_YET_RECRUITING
New York
Weill Cornell Medicine - Cutaneous Oncology and Melanoma Program
NOT_YET_RECRUITING
New York
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
RECRUITING
Philadelphia
Tennessee
Sarah Cannon Research Institute - Oncology Partners
RECRUITING
Nashville
Texas
MD Anderson
NOT_YET_RECRUITING
Houston
The University of Texas MD Anderson Cancer Center Houston, Texas 77030-4000
NOT_YET_RECRUITING
Houston
Next Oncology Dallas
RECRUITING
Irving
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Washington
Seattle Cancer Care Alliance
NOT_YET_RECRUITING
Seattle
Swedish Cancer Institute
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
Chris O'Brien Lifehouse
NOT_YET_RECRUITING
Camperdown
Cabrini Hospital - Malvern
NOT_YET_RECRUITING
Clayton
Brazil
Hospital de Câncer de Barretos - Fundação Pio XII
NOT_YET_RECRUITING
Barretos
Hospital de Clínicas de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Faculdade de Medicina de Sao Jose do Rio Preto-SP - Hospital de Base
NOT_YET_RECRUITING
São José Do Rio Preto
Next Brasil (Rede D'Or)
NOT_YET_RECRUITING
São Paulo
Republic of Korea
Chungbuk National University Hospital
NOT_YET_RECRUITING
Cheongju-si
National Cancer Center
NOT_YET_RECRUITING
Gyeonggi-do
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Severance Hospital - Yonsei Cancer Center
NOT_YET_RECRUITING
Seoul
Spain
Hospital Universitario Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Hopsital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Contact Information
Primary
IDEAYA Clinical Trials
IDEAYAClinicalTrials@ideayabio.com
+1-855-433-2246
Time Frame
Start Date: 2025-10-14
Estimated Completion Date: 2029-05
Participants
Target number of participants: 208
Treatments
Experimental: 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: Experimental: Part 1B IDE849 + durvalumab (Dose Escalation)
Multiple doses of IDE849 will be tested in combination with durvalumab to identify the optimal combination dose.
Experimental: 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: Experimental: Part 2 IDE849 Monotherapy (Dose Expansion)
Chosen monotherapy doses of IDE849 will be tested in additional participants.
Experimental: Experimental: Part 2 IDE849 + durvalumab (Dose Expansion)
Chose combination dose of IDE849 + durvalumab will be tested in additional participants.
Experimental: Experimental: Part 2 IDE849 + IDE161 (Dose Expansion)
Chose combination dose of IDE849 + IDE161 will be testing in additional participants
Sponsors
Leads: IDEAYA Biosciences

This content was sourced from clinicaltrials.gov

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