Clinical Trials /

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

NCT04032704

Description:

This trial will study Ladiratuzumab Vedotin (LV) to find out whether it is an effective treatment for different types of solid tumors and what side effects (unwanted effects) may occur.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Squamous Cell Carcinoma
  • Gastric Adenocarcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
  • Official Title: Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: SGNLVA-005
  • NCT ID: NCT04032704

Conditions

  • Small Cell Lung Cancer
  • Non-small Cell Lung Cancer, Squamous
  • Non-small Cell Lung Cancer, Non-squamous
  • Head and Neck Squamous Cell Carcinoma
  • Esophageal Squamous Cell Carcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

DrugSynonymsArms
ladiratuzumab vedotinSGN-LIV1A

Purpose

This trial will study Ladiratuzumab Vedotin (LV) to find out whether it is an effective treatment for different types of solid tumors and what side effects (unwanted effects) may occur.

Detailed Description

      This trial is designed to assess the activity, safety, and tolerability of LV for the
      treatment of solid tumors. Up to 30 subjects will be included in each of the following
      cohorts:

        -  Cohort 1: small cell lung cancer (SCLC)

        -  Cohort 2: non-small cell lung cancer-squamous (NSCLC-squamous)

        -  Cohort 3: non-small cell lung cancer-nonsquamous (NSCLC-nonsquamous)

        -  Cohort 4: head and neck squamous cell carcinoma (HNSCC)

        -  Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous)

        -  Cohort 6: gastric and gastroesophageal junction (GEJ) adenocarcinoma

      Subjects will continue to receive study treatment until disease progression, unacceptable
      toxicity, investigator decision, consent withdrawal, study termination by the sponsor,
      pregnancy, or death, whichever comes first.
    

Trial Arms

NameTypeDescriptionInterventions
SGN-LIV1AExperimental
  • ladiratuzumab vedotin

Eligibility Criteria

        Inclusion Criteria:

          -  All Cohorts

               -  Measurable disease according to RECIST v1.1 as assessed by the investigator

               -  Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1

          -  Cohort 1: SCLC

               -  Must have extensive stage disease

               -  No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage

               -  May have received prior anti-PD(L)1 therapy

          -  Cohort 2: NSCLC-squamous

               -  Must have unresectable locally advanced or metastatic disease

               -  Must have disease progression during or following systemic therapy

                    1. Participants must have progressed during or after a platinum-based
                       combination therapy administered for the treatment of metastatic disease

                    2. Participants must have progressed within 6 months of last dose of
                       platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or
                       concomitant chemoradiation regimen for early stage or locally advanced stage
                       disease.

               -  No more than 1 prior line of cytotoxic chemotherapy for their advanced disease

               -  Must have received prior anti-PD(L)1 therapy, unless contraindicated

          -  Cohort 3: NSCLC-nonsquamous

               -  Must have unresectable locally advanced or metastatic disease

               -  Must have disease progression during or following systemic therapy

                    1. Participants must have progressed during or after a platinum-based
                       combination therapy administered for the treatment of metastatic disease

                    2. Participants must have progressed within 6 months of last dose of
                       platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or
                       concomitant chemoradiation regimen for early stage or locally advanced state
                       disease.

               -  Must have had prior platinum-based chemotherapy

               -  No more than 1 prior line of cytotoxic chemotherapy for their advanced disease

               -  Must have received prior anti-PD(L)1 therapy, unless contraindicated

          -  Cohort 4: HNSCC

               -  Must have unresectable locally recurrent or metastatic disease

               -  Must have disease progression during or following prior line of systemic therapy

                    1. Disease progression after treatment with a platinum-containing regimen for
                       recurrent/metastatic disease; or

                    2. Recurrence/progression within 6 months of last dose of platinum therapy
                       given as part of a multimodal therapy in the curative setting

               -  No more than 1 line of cytotoxic chemotherapy for their advanced disease

               -  May have received prior anti-PD(L)1 therapy, unless contraindicated

          -  Cohort 5: esophageal-squamous

               -  Must have unresectable locally advanced or metastatic disease

               -  Must have disease progression during or following systemic therapy

               -  Must have had prior platinum-based chemotherapy

               -  No more than 1 line of cytotoxic chemotherapy for their advanced disease

          -  Cohort 6: gastric and GEJ adenocarcinoma

               -  Must have unresectable locally advanced or metastatic disease

               -  Must have received prior platinum-based therapy

               -  Must have disease progression during or following systemic therapy

               -  Participants with known human epidermal growth factor receptor 2 (HER2)
                  overexpression must have received prior HER2-targeted therapy

               -  No more than 1 line of prior cytotoxic chemotherapy for their advanced disease

        Exclusion Criteria:

          -  Active concurrent malignancy or a previous malignancy within the past 3 years

          -  Known active central nervous system lesions

          -  Any ongoing clinically significant toxicity associated with prior treatment (Grade 2
             or higher)

          -  Ongoing sensory or motor neuropathy of Grade ≥2

          -  Has received prior radiotherapy within 2 weeks of start of study treatment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Confirmed objective response rate (ORR) as determined by investigator according to RECIST v1.1
Time Frame:Up to approximately 1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of participants with adverse events (AEs)
Time Frame:Up to approximately 1 year
Safety Issue:
Description:
Measure:Disease control rate (DCR) as determined by investigator according to RECIST v1.1
Time Frame:Up to approximately 1 year
Safety Issue:
Description:
Measure:Duration of response (DOR) as determined by investigator according to RECIST v1.1
Time Frame:Up to approximately 1 year
Safety Issue:
Description:
Measure:Progression-free survival (PFS) as determined by investigator according to RECIST v1.1
Time Frame:Up to approximately 1 year
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to approximately 1 year
Safety Issue:
Description:
Measure:Maximum observed concentration (Cmax)
Time Frame:Up to approximately 1 year
Safety Issue:
Description:Pharmacokinetic (PK) endpoint of LV
Measure:Area under the concentration-time curve (AUC)
Time Frame:Up to approximately 1 year
Safety Issue:
Description:PK endpoint of LV
Measure:Incidence of antitherapeutic antibodies (ATAs) to LV
Time Frame:Up to approximately 1 year
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • SCLC
  • NSCLC-squamous
  • NSCLC-nonsquamous
  • HNSCC
  • GEJ adenocarcinoma

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