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: Terminated
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab 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: f
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 (Parts A and B)

‣ 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 (Parts A and B)

‣ 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 (Parts A and B)

‣ 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 (Parts A and B)

‣ 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 (Parts A and B)

‣ 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 (Parts A and B)

‣ 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 (Part B only)

‣ 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 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 known breast cancer gene (BRCA) mutations are excluded

⁃ No prior radioisotope therapy or radiotherapy to ≥30% of bone marrow

• Cohort 8: Melanoma (Parts B and C)

‣ 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 progressive disease following anti-PD(L)1 therapy

⁃ Must have received BRAF +/- MEK inhibitor therapy if BRAF mutated (Part C)

Locations
United States
Arizona
Ironwood Cancer & Research Centers - Chandler
Chandler
California
Adventist Health White Memorial
Los Angeles
Providence Medical Foundation
Santa Rosa
Connecticut
Eastern CT Hematology and Oncology Associates
Norwich
Florida
GenesisCare USA
Jacksonville
AdventHealth Cancer Institute
Orlando
Georgia
IACT Health
Columbus
Illinois
Northwestern University
Chicago
Decatur Memorial Hospital - Illinois
Decatur
Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne
Maryland
University of Maryland
Baltimore
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Minnesota
HealthPartners Institute
Saint Louis Park
North Carolina
FirstHealth of the Carolinas
Pinehurst
New Jersey
Valley Hospital, The / Luckow Pavilion
Paramus
New Mexico
San Juan Oncology Associates
Farmington
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
Weill Cornell Medicine
New York
Stony Brook University Cancer Center
Stony Brook
Ohio
Gabrail Cancer Center Research, LLC
Canton
Oregon
Providence Portland Medical Center
Portland
South Carolina
Saint Francis Hospital / Bon Secours - South Carolina
Greenville
Tennessee
Erlanger Oncology and Hematology
Chattanooga
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville
Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock
UT Health East Texas Hope Cancer Center
Tyler
Wisconsin
Carbone Cancer Center / University of Wisconsin
Madison
Other Locations
Australia
Flinders Medical Centre
Bedford Park
Townsville Cancer Center
Douglas
Peninsula and South East Oncology
Frankston
Central Coast Local Health District (Gosford and Wyong Hospitals)
Gosford
Royal Hobart Hospital
Hobart
Cabrini
Malvern
St Vincents Hospital Sydney
Sydney
Melanoma Institute Australia
Wollstonecraft
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna
Azienda Ospedaliero Universitaria Careggi
Firenze
ASL 3 Genovese Villa Scassi Hospital
Genova
San Luca Hospital
Lucca
Irccs Irst
Meldola
Niguarda Ca' Granda Hospital
Milan
Istituto Europeo di Oncologia
Milano
Fondazione IRCCS San Gerardo dei Tintori
Monza
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli
Policlinico Universitario Agostino Gemelli
Roma
AOUS Policlinico Le Scotte
Siena
Republic of Korea
Dong-A University Hospital
Busan
Chonnam National University Hwasun Hospital
Hwasun
Seoul National University Bundang Hospital
Seongnam-si
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Ajou University Hospital
Suwon-si
St. Vincent's Hospital, The Catholic University of Korea
Suwon-si
Taiwan
Taichung Veterans General Hospital
Taichung
National Cheng-Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow
Sarah Cannon Research Institute UK
London
The Royal Marsden Hospital
London
UCL Cancer Institute
London
The Christie NHS Foundation Trust
Manchester
The Royal Marsden Hospital (Surrey)
Sutton
Time Frame
Start Date: 2019-10-09
Completion Date: 2023-11-28
Participants
Target number of participants: 205
Treatments
Experimental: Part A: Non-randomized LV monotherapy
Monotherapy dosing schedule 1.
Experimental: Part B: Non-randomized LV monotherapy
Monotherapy dosing schedule 2.
Experimental: Part C - Arm 1: Randomized LV monotherapy
Monotherapy dosing schedule 3.
Experimental: Part C - Arm 2: Randomized LV combination therapy
Combination dosing schedule 1.
Experimental: Part C - Arm 3: Randomized LV combination therapy
Combination dosing schedule 2.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Seagen Inc.

This content was sourced from clinicaltrials.gov

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