Lung Cancer Clinical Trial
Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Summary
This study intends to define the recommended Phase 2 dose of DS-7300a based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and to investigate DS7300a anti-tumor activity in this population.
Full 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 platinum-based chemotherapy and a maximum of 3 prior lines of therapy will be enrolled. Two I-DXd doses will be tested (8 mg/kg Q3W and 12 mg/kg Q3W). In the extension part of the study (Part 2), approximately 70 participants with a minimum of two previous lines of systemic therapy will be enrolled. I-DXd will be administered at the selected dose of 12 mg/kg Q3W.
In Part 1, eligible participants will be randomized in a 1:1 ratio to receive one of the two dose levels of I-DXd. Randomization will be stratified by:
Prior receipt or of an anti-programmed death-ligand 1 (PD-[L]1) antibody (yes/no)
The chemotherapy-free interval (CTFI) from completion of the first-line therapy to the date of documented radiological Progressive Disease of <90 days vs. ≥90 days in second-line participants as well as the number of lines of therapy. Thus, the stratification factor includes three categories: (1) second-line participants with CTFI <90 days, (2) second-line participants with CTFI ≥90 days, and (3) third- and fourth-line participants.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There are 73 Locations for this study
Springdale Arkansas, 72762, United States More Info
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Springdale Arkansas, 72762, United States
Jacksonville Florida, 32256, United States More Info
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Jacksonville Florida, 32256, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States More Info
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Chicago Illinois, 60637, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States More Info
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Grand Rapids Michigan, 49503, United States
Saint Louis Missouri, 63110, United States More Info
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Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States More Info
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Manahawkin New Jersey, 08050, United States
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Bronx New York, 10461, United States
New York New York, 10021, United States More Info
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New York New York, 10065, United States
Durham North Carolina, 27703, United States
Durham North Carolina, 27710, United States More Info
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Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States More Info
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Houston Texas, 77090, United States
Houston Texas, 77090, United States More Info
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Seattle Washington, 98109, United States More Info
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Seattle Washington, 98195, United States
Madison Wisconsin, 53705, United States
Wien , 1210, Austria
Wuhan Hubei, 43002, China More Info
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Chengdu Sichuan, 61113, China More Info
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Changchun , 13001, China
Changsha , 41001, China
Chengdu , 61004, China
Guangdong , 51000, China
Hangzhou , 31002, China
Linyi , 27600, China
Shanghai , 20003, China
Wuhan , 43002, China
Créteil , 94000, France
Lyon , 69008, France
Marseille cedex 20 , 13915, France
Montpellier cedex 05 , 34295, France
Montpellier , 34295, France More Info
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Paris Cedex 05 , 75005, France
Paris , 75020, France
Paris , 94000, France
Berlin , 13125, Germany
Dresden , 1307, Germany
Essen , 45147, Germany
Kashiwa-shi Chiba-Ken, 277-8, Japan More Info
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Osaka-shi Osaka-Fu, 541-8, Japan More Info
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Osakasayama-shi Osaka-Fu, 589-8, Japan More Info
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Koto-ku Tokyo-To, 135-8, Japan More Info
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Chuo-ku , 104-0, Japan
Kashiwa , 277-8, Japan
Koto-ku , 135-8, Japan
Osaka-Sayama , 589-8, Japan
Osaka , 541-8, Japan
Sunto-gun , 411-8, Japan
Yokohama , 241-8, Japan
Goyang-si Gyeonggi-do, 10408, Korea, Republic of More Info
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Goyan-si , 10408, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
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A Coruña , 15006, Spain More Info
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A Coruña , 15006, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain More Info
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L'Hospitalet de Llobregat , 08908, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Malaga , 29011, Spain
Sevilla , 41009, Spain
Kaohsiung City , 833, Taiwan More Info
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Kaohsiung , 83301, Taiwan
Taichung , 40705, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei City , 10022, Taiwan
Taoyuan City , 33305, Taiwan More Info
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Taoyuan , 333, Taiwan
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