Clinical Trial 21986

• Overview

  Study Title:

  A Phase 2, Multicenter, Randomized, Open-Label Study of DS-7300a, a B7-H3 Antibody Drug Conjugate (ADC), in Subjects with Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

  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 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).

  Objective:

  Primary To investigate the anti-tumor activity of DS-7300a in subjects with pretreated ESSCLC Secondary To assess the safety and tolerability of DS-7300a in subjects with pretreated ESSCLC To further investigate the anti-tumor activity of DS-7300a in subjects with pretreated ES-SCLC To evaluate the pharmacokinetics (PK) of DS-7300a To assess the immunogenicity of DS-7300a

• Treatments

  Therapies:

  Antibody-Drug Conjugate

  Medications:

  DS-7300a ()

• Inclusion Criteria

  Inclusion Criteria:
  • 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 or older
  • 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

  Exclusion Criteria:
  • 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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