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Trial record 1 of 1 for:    NCT04032704
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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 : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Tracking Information
First Submitted Date  ICMJE July 23, 2019
First Posted Date  ICMJE July 25, 2019
Last Update Posted Date July 29, 2021
Actual Study Start Date  ICMJE October 9, 2019
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Confirmed objective response rate (ORR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
    Confirmed ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator.
  • Prostate-specific antigen (PSA) response rate as determined by investigator according to Prostate Cancer Clinical Trials Working Group 3 criteria (Cohort 7 only) [ Time Frame: Up to approximately 1 year ]
    Confirmed PSA response rate is defined as the proportion of participants with a reduction from baseline PSA level of at leat 50%, measured twice ≥3 weeks apart
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
Confirmed objective response rate (ORR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Number of participants with adverse events (AEs) [ Time Frame: Up to approximately 1 year ]
  • Disease control rate (DCR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
    DCR is defined as the proportion of participants who achieve a confirmed CR or PR, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks.
  • Duration of response (DOR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
    DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or death due to any cause, whichever comes first.
  • PSA-DOR as determined by investigator assessment (Cohort 7 only) [ Time Frame: Up to approximately 1 year ]
    PSA-DOR is defined as the time from the first documentation of PSA response to the first documentation of PSA progression or death, whichever comes first
  • Progression-free survival (PFS) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
    Progression-free survival (PFS) is defined as the time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first.
  • PSA-PFS as determined by investigator assessment (Cohort 7 only) [ Time Frame: Up to approximately 1 year ]
    PSA-PFS is defined as the time from the start of study treatment to first occurrence of PSA progression or death, whichever comes first
  • Overall survival (OS) [ Time Frame: Up to approximately 1 year ]
    OS is defined as the time from the start of study treatment to date of death due to any cause.
  • Maximum observed concentration (Cmax) [ Time Frame: Up to approximately 1 year ]
    Pharmacokinetic (PK) endpoint of LV
  • Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 1 year ]
    PK endpoint of LV
  • Incidence of antitherapeutic antibodies (ATAs) to LV [ Time Frame: Up to approximately 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • Number of participants with adverse events (AEs) [ Time Frame: Up to approximately 1 year ]
  • Disease control rate (DCR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
  • Duration of response (DOR) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
  • Progression-free survival (PFS) as determined by investigator according to RECIST v1.1 [ Time Frame: Up to approximately 1 year ]
  • Overall survival (OS) [ Time Frame: Up to approximately 1 year ]
  • Maximum observed concentration (Cmax) [ Time Frame: Up to approximately 1 year ]
    Pharmacokinetic (PK) endpoint of LV
  • Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 1 year ]
    PK endpoint of LV
  • Incidence of antitherapeutic antibodies (ATAs) to LV [ Time Frame: Up to approximately 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Official Title  ICMJE Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors
Brief Summary This trial will study ladiratuzumab vedotin (LV) to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.
Detailed Description

This trial is designed to assess the antitumor activity, safety, and tolerability of LV for the treatment of solid tumors. Participants with the following advanced solid tumors will be enrolled:

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 Cohort 7: castration-resistant prostate cancer (CRPC) Cohort 8: melanoma

Participants 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
  • Prostate Cancer
  • Melanoma
Intervention  ICMJE Drug: ladiratuzumab vedotin
Intravenous (into the vein; IV) infusion
Other Name: SGN-LIV1A
Study Arms  ICMJE Experimental: Ladiratuzumab Vedotin
SGN-LIV1A monotherapy
Intervention: Drug: ladiratuzumab vedotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)
264
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2019)
180
Estimated Study Completion Date  ICMJE July 31, 2023
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
    • Must have disease progression during or following prior platinum-based systemic chemotherapy for extensive stage disease;
    • No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
    • 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

      • Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
      • 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.
    • Participants with known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other actionable mutations are not eligible
    • 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

      • Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
      • 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.
    • Participants with known EGFR, ALK, ROS, BRAF, tropomyosin receptor kinase (TRK), or other actionable mutations are not eligible
    • 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
      • Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; or
      • 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
    • Participants may have received prior anti-PD(L)1 therapy, unless contraindicated
  • Cohort 7: CRPC

    • Must have histologically or cytologically confirmed adenocarcinoma of the prostate

      • Participants with components of small cell of neuroendocrine histology are excluded
    • Must have metastatic castration-resistant disease
    • Must have been ≥28 days between cessation of androgen receptor-targeted therapy and start of study treatment
    • Must have received no more than 1 prior line of androgen receptor-targeted therapy for metastatic castration-sensitive prostate cancer or CRPC
    • No prior cytotoxic chemotherapy in the metastatic CRPC setting

      • For participants who received cytotoxic chemotherapy in CSPC, at least 6 months must have elapsed between last dose of chemotherapy and start of study treatment
      • No more than 1 prior line of cytotoxic chemotherapy for CSPC
    • Participants with measurable and non-measurable disease are eligible if the following criteria are met:

      • A minimum starting PSA level ≥1.0 ng/mL
      • Participants with measurable soft tissue disease must have evidence of measurable soft tissue disease according to PCWG3 criteria.
      • Participants with non-measurable disease must have documented rising PSA levels or appearance of new lesion according to PCWG3
    • Participants with known breast cancer gene (BRCA) mutations are excluded
    • No prior radioscope therapy or radiotherapy to ≥30% of bone marrow
  • Cohort 8: Melanoma

    • Must have histologically or cytotoxically confirmed cutaneous malignant melanoma

      • Participants with mucosal, acral, or uveal melanoma are excluded
    • Must have locally advanced unresectable or metastatic stage disease
    • Must have measurable disease
    • Must have progressive disease following anti-PD(L)1 therapy

Exclusion Criteria

  • Active concurrent malignancy or a previous malignancy within the past 3 years
  • Any anticancer therapy within 3 weeks of starting study treatment. Participants who are/were on adjuvant hormonal therapy for the treatment of malignancies with negligible risk of metastases are eligible.
  • Known active central nervous system lesions
  • Active viral, bacterial, or fungal infection requiring systemic treatment within 7 days prior to the first dose of LV
  • Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher)
  • Ongoing sensory or motor neuropathy of Grade ≥2
  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure
  • Has received prior radiotherapy within 2 weeks of start of study treatment
  • Has received a live vaccine within 30 days of the planned start of study therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE Australia,   Italy,   Korea, Republic of,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04032704
Other Study ID Numbers  ICMJE SGNLVA-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seagen Inc.
Study Sponsor  ICMJE Seagen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zejing Wang, MD, PhD Seagen Inc.
PRS Account Seagen Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP