The trial is taking place at:
D

Duke University Health System | Duke Gastroenterology Clinic - Clinic 2

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Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)

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Daiichi Sankyo

Status and phase

Enrolling
Phase 2

Conditions

Extensive-stage Small-cell Lung Cancer

Treatments

Drug: Ifinatamab Deruxtecan (I-DXd)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05280470
DS7300-127
2022-000503-13 (EudraCT Number)
2041220019 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

Ifinatamab Deruxtecan (8 mg/kg)
Experimental group
Description:
Participants will be randomized to receive I-DXd at 8 mg/kg.
Treatment:
Drug: Ifinatamab Deruxtecan (I-DXd)
Ifinatamab Deruxtecan (12 mg/kg)
Experimental group
Description:
Participants will be randomized to receive I-DXd at 12 mg/kg. In Part 2, all participants will receive I-DXd 12 mg/kg.
Treatment:
Drug: Ifinatamab Deruxtecan (I-DXd)

Trial contacts and locations

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Central trial contact

(US contact) Daiichi Sankyo Contact for Clinical Trial Information; Daiichi Sankyo Contact for Clinical Trial Information

Data sourced from clinicaltrials.gov

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