Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Running, not enrolling · Phase 2

Conditions studied: Extensive-stage Small-cell Lung Cancer

In brief

This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy (Part 1) and a minimum of two previous lines of systemic therapy (Part 2). This study will also investigate I-DXd anti-tumor activity in this population.

Key facts

Study ID

NCT05280470

Run by

Daiichi Sankyo

People needed

187

Starts

2022-03-09

Expected to finish

2026-12-15

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all the following criteria to be eligible for enrollment into the study:
• Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
• Participant must have at least one lesion, not previously irradiated, amenable to core biopsy.
• Male or female subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
• Histologically or cytologically documented ES-SCLC.
• At least one measurable lesion according to RECIST v1.1 as assessed by the investigator.
• Prior therapy with at least one platinum-based line as systemic therapy for extensive-stage disease with at least two cycles of therapy (except in the case of early objective PD) and beginning with protocol version 3.0, a minimum of two previous lines of systemic therapy.
• Documentation of radiological disease progression on or after most recent systemic therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

You may not qualify if…

• Participants who meet any of the following criteria will be disqualified from entering the study:
• Prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
• Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
• Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
• Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
• Clinically significant corneal disease.
• Uncontrolled or significant cardiovascular disease.
• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses,
• Chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions) or intra-articular steroid injections.
• History of malignancy other than SCLC within the 3 years prior to enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal (GI) tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
• History of allogeneic bone marrow, stem cell, or solid organ transplant.
• Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0), Grade ≤1 or baseline.
• History of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
• Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
• Has active or uncontrolled hepatitis B or C infection.
• Active, known, or suspected autoimmune disease.
• Any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness/social situations, substance abuse).
• Has received a live vaccine within 30 days prior to the first dose of study drug.
• Female who is pregnant or breast-feeding or intends to become pregnant during the study.
• Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant.
• Known human immunodeficiency virus (HIV) infection that is not well controlled.

Where it is running

• The Cancer Specialists, Llc — Jacksonville, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dana-Faeber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack Meridian Health-Southern Ocean Medical Center — Manahawkin, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center (Mskcc) - New York — New York, New York, United States
• Montefiore Medical Center Prime — The Bronx, New York, United States
• Duke University Health System — Durham, North Carolina, United States
• Sarah Cannon (Tennessee Oncology - Nashville) — Nashville, Tennessee, United States
• Millennium Physicians Association, Llp — Houston, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Jilin Cancer Hospital — Changchun, China
• Hunan Cancer Hospital — Changsha, China
• West China Hospital, Sichuan University — Chengdu, China
• Guangdong Provincial People'S Hospital — Guangdong, China
• Zhejiang Cancer Hospital — Hangzhou, China
• Linyi Cancer Hospital — Linyi, China
• Fudan University Shanghai Cancer Center — Shanghai, China
• Union Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
• Centre Hospitalier Intercommunal de Créteil — Créteil, France
• Highlands Oncology Group — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

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