Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

Who is this study for? Adult patients with Small or Non-Small Squamous or Cell Lung Cancer
What treatments are being studied? Ladiratuzumab Vedotin
Status: Recruiting
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

• 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 cytologically 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

Locations
United States
Arizona
Ironwood Cancer & Research Centers - Chandler
Recruiting
Chandler
California
Adventist Health White Memorial
Completed
Los Angeles
Saint Joseph Heritage Medical Group
Completed
Santa Rosa
Connecticut
Eastern CT Hematology and Oncology Associates
Recruiting
Norwich
Florida
GenesisCare USA
Recruiting
Jacksonville
AdventHealth Cancer Institute
Recruiting
Orlando
Georgia
IACT Health
Completed
Columbus
Illinois
Northwestern University
Recruiting
Chicago
Decatur Memorial Hospital
Recruiting
Decatur
Indiana
Fort Wayne Medical Oncology and Hematology
Recruiting
Fort Wayne
Maryland
University of Maryland
Completed
Baltimore
Michigan
University of Michigan Comprehensive Cancer Center
Completed
Ann Arbor
Minnesota
HealthPartners Institute
Recruiting
Saint Louis Park
North Carolina
FirstHealth of the Carolinas
Recruiting
Pinehurst
New Jersey
Valley Hospital, The / Luckow Pavilion
Recruiting
Paramus
New Mexico
San Juan Oncology Associates
Recruiting
Farmington
Nevada
Comprehensive Cancer Centers of Nevada
Recruiting
Las Vegas
New York
Weill Cornell Medicine
Recruiting
New York
Stony Brook University Cancer Center
Recruiting
Stony Brook
Ohio
Gabrail Cancer Center Research, LLC
Recruiting
Canton
Oregon
Providence Portland Medical Center
Completed
Portland
South Carolina
Saint Francis Hospital / Bon Secours
Recruiting
Greenville
Tennessee
Erlanger Oncology and Hematology
Completed
Chattanooga
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Recruiting
Nashville
Texas
Joe Arrington Cancer Research and Treatment Center
Recruiting
Lubbock
UT Health East Texas Hope Cancer Center
Recruiting
Tyler
Wisconsin
Carbone Cancer Center / University of Wisconsin
Recruiting
Madison
Other Locations
Australia
Flinders Medical Centre
Recruiting
Bedford Park
Townsville Cancer Center
Recruiting
Douglas
Peninsula and South East Oncology
Recruiting
Frankston
Central Coast Local Health District (Gosford and Wyong Hospitals)
Recruiting
Gosford
Royal Hobart Hospital
Recruiting
Hobart
Cabrini
Recruiting
Malvern
St Vincents Hospital Sydney
Recruiting
Sydney
Melanoma Institute Australia
Recruiting
Wollstonecraft
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Recruiting
Bologna
Azienda Ospedaliero Universitaria Careggi
Recruiting
Florence
ASL 3 Genovese Villa Scassi Hospital
Recruiting
Genova
San Luca Hospital
Recruiting
Lucca
Irccs Irst
Recruiting
Meldola
Niguarda Ca' Granda Hospital
Recruiting
Milan
Istituto Europeo di Oncologia
Recruiting
Milano
San Gerardo di Monza Hospital
Recruiting
Monza
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Recruiting
Napoli
Policlinico Universitario Agostino Gemelli
Recruiting
Rome
AOUS Policlininico Le Scotte
Recruiting
Siena
Republic of Korea
Dong-A University Hospital
Recruiting
Busan
Chonnam National University Hwasun Hospital
Recruiting
Hwasun
Seoul National University Bundang Hospital
Recruiting
Seongnam-si
Korea University Guro Hospital
Recruiting
Seoul
Samsung Medical Center
Recruiting
Seoul
Seoul National University Boramae Medical Center
Recruiting
Seoul
Seoul National University Hospital
Recruiting
Seoul
Severance Hospital, Yonsei University Health System
Recruiting
Seoul
Ajou University Hospital
Recruiting
Suwon-si
St. Vincent's Hospital, The Catholic University of Korea
Recruiting
Suwon-si
Taiwan
Taichung Veterans General Hospital
Recruiting
Taichung
National Cheng-Kung University Hospital
Recruiting
Tainan
National Taiwan University Hospital
Recruiting
Taipei
Taipei Medical University Hospital
Recruiting
Taipei
United Kingdom
The Beatson West of Scotland Cancer Centre
Recruiting
Glasgow
Sarah Cannon Research Institute UK
Recruiting
London
The Royal Marsden Hospital
Recruiting
London
UCL Cancer Institute
Recruiting
London
The Christie NHS Foundation Trust
Recruiting
Manchester
The Royal Marsden Hospital (Surrey)
Recruiting
Sutton
Contact Information
Primary
Seagen Trial Information Support
clinicaltrials@seagen.com
866-333-7436
Time Frame
Start Date: October 9, 2019
Estimated Completion Date: July 31, 2025
Participants
Target number of participants: 264
Treatments
Experimental: Ladiratuzumab Vedotin
SGN-LIV1A monotherapy
Sponsors
Leads: Seagen Inc.

This content was sourced from clinicaltrials.gov

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