Prostate Cancer Clinical Trial

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

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.

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Full 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.

View Eligibility Criteria

Eligibility 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
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 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

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

264

Study ID:

NCT04032704

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 66 Locations for this study

See Locations Near You

Ironwood Cancer & Research Centers - Chandler
Chandler Arizona, 85224, United States More Info
Erin Gillam
Contact
480-314-6685
[email protected]
Sujith Kalmadi
Principal Investigator
Adventist Health White Memorial
Los Angeles California, 90033, United States
Saint Joseph Heritage Medical Group
Santa Rosa California, 95403, United States
Eastern CT Hematology and Oncology Associates
Norwich Connecticut, 06360, United States More Info
Susan Johnson
Contact
860-886-8362
[email protected]
Dennis Slater
Principal Investigator
GenesisCare USA
Jacksonville Florida, 32204, United States More Info
Rachel Novella
Contact
239-938-9315
[email protected]
Troy Guthrie
Principal Investigator
AdventHealth Cancer Institute
Orlando Florida, 32804, United States More Info
Rosangela Spear
Contact
407-303-2090
[email protected]
Tarek Mekhail
Principal Investigator
IACT Health
Columbus Georgia, 31904, United States More Info
Liery Williams
Contact
[email protected]
Andrew Pippas
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Amanda Clark
Contact
312-695-8070
[email protected]
Mary Mulcahy
Principal Investigator
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
James Wade III
Principal Investigator
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46804, United States More Info
Shelley Seabolt
Contact
260-969-7818
[email protected]
Sunil Babu
Principal Investigator
University of Maryland
Baltimore Maryland, 21201, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
HealthPartners Institute
Saint Louis Park Minnesota, 55416, United States More Info
Michele Lacy
Contact
952-993-1516
[email protected]
Daniel Anderson
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States More Info
Henry Igid
Contact
702-952-3400
[email protected]
Nicholas Vogelzang
Principal Investigator
Valley Hospital, The / Luckow Pavilion
Paramus New Jersey, 07652, United States More Info
Taja Fergurson
Contact
201-389-0198
[email protected]
Eli Kirshner
Principal Investigator
San Juan Oncology Associates
Farmington New Mexico, 87401, United States More Info
Rosemary Benton
Contact
860-886-8362
[email protected]
Sardar Imam
Principal Investigator
Weill Cornell Medicine
New York New York, 10065, United States More Info
Manish Shah
Contact
646-962-6200
[email protected]
Manish Shah
Principal Investigator
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States More Info
Amna Sher
Principal Investigator
FirstHealth of the Carolinas
Pinehurst North Carolina, 28374, United States More Info
Julie Williams
Contact
910-715-1922
[email protected]
Charles Kuzma
Principal Investigator
Gabrail Cancer Center Research, LLC
Canton Ohio, 44718, United States More Info
Carrie Smith
Contact
330-492-3345
[email protected]
Nashat Gabrail
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States
Saint Francis Hospital / Bon Secours
Greenville South Carolina, 29601, United States More Info
Gina Smith
Contact
864-603-6220
[email protected]
Robert Siegel
Principal Investigator
Erlanger Oncology and Hematology
Chattanooga Tennessee, 37403, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Misty Moore
Contact
615-524-4025
[email protected]
David Spigel
Principal Investigator
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States More Info
Sonia Salas
Contact
806-725-8068
[email protected]
Isaac Tafur
Principal Investigator
UT Health East Texas Hope Cancer Center
Tyler Texas, 75701, United States More Info
Arielle Lee
Principal Investigator
Carbone Cancer Center / University of Wisconsin
Madison Wisconsin, 53792, United States More Info
Carbone Cancer Center Laboratory Inbox
Contact
[email protected]
Justine Bruce
Principal Investigator
Melanoma Institute Australia
Wollstonecraft Other, 2065, Australia More Info
Georgina Long
Principal Investigator
Flinders Medical Centre
Bedford Park , 5042, Australia More Info
Christos Karapetis
Principal Investigator
Townsville Cancer Center
Douglas , 4814, Australia More Info
Abhishek Joshi
Principal Investigator
Peninsula and South East Oncology
Frankston , 3199, Australia More Info
Vinod Ganju
Principal Investigator
Central Coast Local Health District (Gosford and Wyong Hospitals)
Gosford , 2250, Australia More Info
Matthew Wong
Principal Investigator
Royal Hobart Hospital
Hobart , 7000, Australia More Info
Louise Nott
Principal Investigator
Cabrini
Malvern , 3144, Australia More Info
Gary Richardson
Principal Investigator
St Vincents Hospital Sydney
Sydney , 2010, Australia More Info
Anthony Joshua
Principal Investigator
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy More Info
Stefania Salvagni
Principal Investigator
Azienda Ospedaliero Universitaria Careggi
Florence , 50134, Italy More Info
Lorenzo Antonuzzo
Principal Investigator
ASL 3 Genovese Villa Scassi Hospital
Genova , 16125, Italy More Info
Manlio Mencoboni
Principal Investigator
San Luca Hospital
Lucca , 55100, Italy More Info
Editta Baldini
Principal Investigator
Irccs Irst
Meldola , 47014, Italy More Info
Ugo De Giorgi
Principal Investigator
Istituto Europeo di Oncologia
Milano , 20141, Italy More Info
Giuseppe Curigliano
Principal Investigator
Niguarda Ca' Granda Hospital
Milan , 20162, Italy More Info
Salvatore Siena
Principal Investigator
San Gerardo di Monza Hospital
Monza , 20900, Italy More Info
Diego Cortinovis
Principal Investigator
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli , 80131, Italy More Info
Paolo Ascierto
Principal Investigator
Policlinico Universitario Agostino Gemelli
Rome , 00168, Italy More Info
Antonia Strippoli
Principal Investigator
AOUS Policlininico Le Scotte
Siena , 53100, Italy More Info
Michele Maio
Principal Investigator
Dong-A University Hospital
Busan , 49201, Korea, Republic of More Info
Sung Yong Oh
Principal Investigator
Chonnam National University Hwasun Hospital
Hwasun , 519-7, Korea, Republic of More Info
In-Jae Oh
Principal Investigator
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of More Info
Jong-Seok Lee
Principal Investigator
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
Do-Youn Oh
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of More Info
Jae Yong Cho
Principal Investigator
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Jeeyun Lee
Principal Investigator
Seoul National University Boramae Medical Center
Seoul , 07671, Korea, Republic of More Info
Jin-Soo Kim
Principal Investigator
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of More Info
Sang Cheul Oh
Principal Investigator
St. Vincent's Hospital, The Catholic University of Korea
Suwon-si , 16247, Korea, Republic of More Info
Byoung Young Shim
Principal Investigator
Ajou University Hospital
Suwon-si , 16499, Korea, Republic of More Info
Hyun Woo Lee
Principal Investigator
Taichung Veterans General Hospital
Taichung , 40705, Taiwan More Info
Tsung-Ying Yang
Principal Investigator
National Cheng-Kung University Hospital
Tainan , 70403, Taiwan More Info
Wu-Chou Su
Principal Investigator
National Taiwan University Hospital
Taipei , 10002, Taiwan More Info
Chia-Chi Lin
Principal Investigator
Taipei Medical University Hospital
Taipei , 110, Taiwan More Info
Po-Li Wei
Principal Investigator
The Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom More Info
Jeff Evans
Principal Investigator
The Royal Marsden Hospital
London , SW3 6, United Kingdom More Info
Ian Chau
Principal Investigator
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom More Info
Hendrik-Tobias Arkenau
Principal Investigator
UCL Cancer Institute
London , WC1E6, United Kingdom More Info
Khurum Khan
Principal Investigator
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom More Info
Matthew Krebs
Principal Investigator
The Royal Marsden Hospital (Surrey)
Sutton , SM2 5, United Kingdom More Info
Ian Chau
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

264

Study ID:

NCT04032704

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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