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A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04032704
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: ladiratuzumab vedotin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SGN-LIV1A Drug: ladiratuzumab vedotin
IV infusion every 21 days




Primary Outcome Measures :
  1. Confirmed objective response rate (ORR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]

Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to approximately 1 year ]
  2. Disease control rate (DCR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
  3. Duration of response (DOR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
  4. Progression-free survival (PFS) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
  5. Overall survival (OS) [ Time Frame: Up to approximately 1 year ]
  6. Maximum observed concentration (Cmax) [ Time Frame: Up to approximately 1 year ]
    Pharmacokinetic (PK) endpoint of LV

  7. Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 1 year ]
    PK endpoint of LV

  8. Incidence of antitherapeutic antibodies (ATAs) to LV [ Time Frame: Up to approximately 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032704


Contacts
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, California
Saint Joseph Heritage Medical Group Recruiting
Santa Rosa, California, United States, 95403
Contact: Teresa Lund    707-521-3814    Teresa.lund@stjoe.org   
Principal Investigator: Ian Anderson, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Christina Lopez    503-215-5696    canrsrchstudies@providence.org   
Principal Investigator: Rachel Sanborn         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Zejing Wang, MD, PhD Seattle Genetics, Inc.

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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT04032704     History of Changes
Other Study ID Numbers: SGNLVA-005
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seattle Genetics, Inc.:
SCLC
NSCLC-squamous
NSCLC-nonsquamous
HNSCC
GEJ adenocarcinoma
Additional relevant MeSH terms:
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Lung Neoplasms
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bronchial Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Esophageal Diseases
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Adenocarcinoma
Small Cell Lung Carcinoma
Squamous Cell Carcinoma of Head and Neck
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Digestive System Diseases
Gastrointestinal Diseases