Status:
ACTIVE_NOT_RECRUITING
Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Extensive-stage Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Extensi...
Detailed Description
This study will consist of 2 parts: dose optimization (Part 1) and extension (Part 2). In the dose optimization part of the study (Part 1), approximately 80 participants with at least 1 prior line of ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2026
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT05280470
Start Date
March 9 2022
End Date
December 15 2026
Last Update
October 28 2025
Active Locations (58)
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1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
2
The Cancer Specialists, Llc
Jacksonville, Florida, United States, 32256
3
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637