Informations générales (source: ClinicalTrials.gov)
A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01) (IDeate-Lung01)
Interventional
Phase 2
Daiichi Sankyo (Voir sur ClinicalTrials)
mars 2022
avril 2025
07 septembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:30:06 | Contacter | ||
| CLCC INSTITUT CURIE | 04/09/2024 13:49:39 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU de Montpellier - Hôpital Arnaud de Villeneuve - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord - Chu Marseille - 13915 - Marseille cedex 20 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.
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.