A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    264
  • sponsor
    Seagen Inc.
Updated on 28 October 2020
Investigator
Seattle Genetics Trial Information Support
Primary Contact
The Townsville Hospital (0.0 mi away) Contact
+42 other location
cancer
systemic therapy
measurable disease
growth factor
metastasis
chemoradiotherapy
epidermal growth factor receptor
extensive disease
human epidermal growth factor
solid tumors
adenocarcinoma
erbb2
squamous cell carcinoma of head and neck
platinum-based chemotherapy

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.

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.

Details
Treatment ladiratuzumab vedotin
Clinical Study IdentifierNCT04032704
SponsorSeagen Inc.
Last Modified on28 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Squamous cell carcinoma or Prostatic disorder or Non-small Cell Lung Cancer, Non-squamous or Non-small Cell L...?
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
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