Trial Title:
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
NCT ID:
NCT06003231
Condition:
Carcinoma, Squamous Cell of Head and Neck
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Endometrial Neoplasms
Conditions: Official terms:
Carcinoma
Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Carcinoma, Squamous Cell
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Disitamab vedotin
Conditions: Keywords:
HNSCC
NSCLC
Ovarian Cancer
Endometrial Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
disitamab vedotin
Description:
Given into the vein (IV, intravenous) every 2 weeks
Arm group label:
Disitamab vedotin monotherapy
Other name:
RC48, RC48-ADC
Summary:
This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor
has grown very large in one spot or has spread to other places in the body, it is called
advanced or metastatic cancer. Participants in this study must have head and neck
squamous cell cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer.
Participants must have tumors that have a marker called HER2.
This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type
of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill
them. In this study, all participants will get DV once every 2 weeks.
This study is being done to see if DV works to treat different types of solid tumors that
express HER2. It will also test how safe the drug is for participants. This trial will
also study what side effects happen when participants get the drug. A side effect is
anything a drug does to your body besides treating the disease.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Cohort 1: Head and neck squamous cell carcinoma (HNSCC)
- Pathologically-documented squamous cell carcinoma of the head and neck with
primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and
larynx
- Unresectable locally recurrent or metastatic stage disease
- Prior therapies:
- Participants must have disease progression after treatment with a
platinum-based therapy
- No more than 1 line of cytotoxic chemotherapy for advanced disease
- Cohort 2: Non-small cell lung cancer (NSCLC)
- Pathologically documented NSCLC
- Unresectable locally-advanced or metastatic stage disease
- Prior therapies
- Must have progressed during or after a platinum-based therapy or, within 6
months of platinum-based adjuvant, neoadjuvant, or concomitant
chemoradiotherapy for early or locally-advanced stage disease
- Must have received prior anti-PD(L)1 therapy, unless contraindicated
- No more than 2 prior lines of cytotoxic chemotherapy for advanced disease
- Cohort 3: Ovarian Cancer
- Pathologically documented epithelial cancers of ovarian, fallopian tube, or
peritoneal origin
- Unresectable locally-advanced or metastatic stage disease
- Prior therapies
- Must have platinum resistant disease (6 months or less between the
completion of platinum-based treatment and identification of recurrence)
- Must not have received more than 4 lines of prior cytotoxic chemotherapies
for advanced disease
- May have received prior anti-PD(L)1 therapy
- Cohort 4: Endometrial Cancer
- Must have pathologically documented adenocarcinoma of the endometrium
- Must have unresectable locally-advanced or metastatic stage disease.
- Prior therapies
- Must have relapsed/progressed after at least one prior platinum-based
chemotherapy for recurrent, metastatic or primary unresectable disease
- Must not have received more than 3 lines of prior cytotoxic chemotherapies
for advanced disease
- May have received prior anti-PD(L)1 therapy
- HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or
archival tumor tissue. Note: Participants with HER2 mutations are eligible.
- Measurable disease per RECIST v1.1 criteria as assessed by the investigator
- Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or
freshly sectioned slides)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria:
- Prior treatment with an MMAE-containing agent.
- Known hypersensitivity to any excipient contained in the drug formulation of
disitamab vedotin.
- History of another invasive malignancy within 2 years before the first dose of study
intervention, or any evidence of residual disease from a previously diagnosed
malignancy.
- Active untreated CNS or leptomeningeal metastasis
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ironwood Cancer & Research Centers - Chandler
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Devanie Heisler
Phone:
480-792-6033 x20195
Investigator:
Last name:
Sujith R Kalmadi
Email:
Principal Investigator
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chemyn Cortez
Phone:
559-360-3707
Email:
chemyn.cortez@valkyrieclinicaltrials.com
Investigator:
Last name:
David Berz
Email:
Principal Investigator
Facility:
Name:
University of California Davis
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Snoti Kumeh
Phone:
916-734-3608
Email:
sakumeh@ucdavis.edu
Investigator:
Last name:
Jonathan W Riess
Email:
Principal Investigator
Facility:
Name:
Providence Medical Foundation
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Camille Shaffer
Phone:
707-521-3809
Investigator:
Last name:
Ian C Anderson
Email:
Principal Investigator
Facility:
Name:
Colorado West Healthcare, dba Grand Valley Oncology
Address:
City:
Grand Junction
Zip:
81505
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial General Email
Phone:
970-644-4460
Email:
gvoclinicaltrials@gjhosp.org
Investigator:
Last name:
Jonathan D King, MD
Email:
Principal Investigator
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Rodriguez Seely
Phone:
203-314-3303
Email:
karen.rodriguezvasquez@yale.edu
Investigator:
Last name:
So Yeon Kim
Email:
Principal Investigator
Facility:
Name:
Eastern CT Hematology and Oncology Associates
Address:
City:
Norwich
Zip:
06360
Country:
United States
Status:
Completed
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patricia Rozas
Phone:
305-243-5601
Email:
pxr445@med.miami.edu
Investigator:
Last name:
Matthew Schlumbrecht
Email:
Principal Investigator
Facility:
Name:
Augusta University
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Donna Wheatley
Phone:
706-721-8978
Email:
dwheatley@augusta.edu
Investigator:
Last name:
Sharad Ghamande
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joyce Liu
Phone:
877-338-7425
Email:
Joyce_Liu@DFCI.HARVARD.EDU
Investigator:
Last name:
Joyce Liu
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute / Wayne State University
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allison Wolgast
Phone:
313-576-8994
Email:
wolgasta@karmanos.org
Investigator:
Last name:
Ammar Sukari
Email:
Principal Investigator
Facility:
Name:
HealthPartners Institute
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chelsea Charlsen
Phone:
952-993-9137
Email:
chelsea.charlsen@parknicollet.com
Investigator:
Last name:
Yan Ji
Email:
Principal Investigator
Facility:
Name:
St. Vincent Frontier Cancer Center
Address:
City:
Billings
Zip:
59102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ali Stonebraker
Email:
Ali.Stonebraker@imail.org
Investigator:
Last name:
Patrick Cobb
Email:
Principal Investigator
Facility:
Name:
Optimum Clinical Research Group, LLC (Southwest Women's Oncology)
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Milena Overby
Phone:
505-372-4270
Email:
moverby@optimumresearchabq.com
Investigator:
Last name:
Karen Finkelstein
Email:
Principal Investigator
Facility:
Name:
NYU Langone Hospital
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Estok
Phone:
212-404-4434
Investigator:
Last name:
Bhavana Pothuri
Email:
Principal Investigator
Facility:
Name:
Mount Sinai Medical Center
Address:
City:
New York
Zip:
10011
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neha Kumarley
Phone:
212-824-7859
Email:
neha.kumarley@mssm.edu
Investigator:
Last name:
Stephanie Blank
Email:
Principal Investigator
Facility:
Name:
NYU Langone Hospital
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anika Tasnim
Email:
Anika.Tasnim@nyulangone.org
Investigator:
Last name:
Bhavana Pothuri
Email:
Principal Investigator
Facility:
Name:
Ruttenberg Treatment Center, Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neha Kumarley
Phone:
212-824-7859
Email:
neha.kumarley@mssm.edu
Investigator:
Last name:
Stephanie Blank
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hollie Watson
Phone:
919-681-3466
Email:
hollie.watson@duke.edu
Investigator:
Last name:
Niharika Mettu
Email:
Principal Investigator
Facility:
Name:
Gabrail Cancer Center Research
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amanda Rich
Phone:
330-492-3345
Email:
arich@gabrailcancercenter.com
Investigator:
Last name:
Nashat Gabrail
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kim Sutcliffe
Phone:
503-215-5763
Email:
kimberly.sutcliffe@providence.org
Investigator:
Last name:
Rachel E Sanborn
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kim Sutcliffe
Phone:
503-215-5763
Email:
kimberly.sutcliffe@providence.org
Investigator:
Last name:
Rachel E Sanborn
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Leta Ko
Phone:
214-648-2279
Email:
lko@tulane.edu
Investigator:
Last name:
David Miller
Email:
Principal Investigator
Facility:
Name:
Renovatio Clinical
Address:
City:
El Paso
Zip:
79915
Country:
United States
Status:
Recruiting
Contact:
Last name:
Corayma Andrade
Phone:
713-703-2398
Investigator:
Last name:
Haroutioun Shahinian
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center / University of Texas
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amber M. Kennon, Ph.D
Phone:
713-745-8661
Email:
amkennon@mdanderson.org
Investigator:
Last name:
Ecaterina E Ileana-Dumbrava
Email:
Principal Investigator
Facility:
Name:
Renovatio Clinical
Address:
City:
The Woodlands
Zip:
77380
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pablo Villarreal
Phone:
713-703-2398
Investigator:
Last name:
Jonathan Lu
Email:
Principal Investigator
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dani Lockert
Phone:
206-215-6266
Email:
dani.lockert@swedish.org
Investigator:
Last name:
Charles Drescher
Email:
Principal Investigator
Facility:
Name:
Fred Hutchinson Cancer Research Center | Seattle, WA
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Wood
Phone:
206-606-2936
Email:
rwood1@fredhutch.org
Investigator:
Last name:
Diane Tseng, MD
Email:
Principal Investigator
Facility:
Name:
Blacktown Hospital
Address:
City:
Blacktown NSW
Zip:
2148
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Bo Gao
Email:
Principal Investigator
Facility:
Name:
Macquarie University Hospital
Address:
City:
Brisbane
Zip:
2109
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
John Park
Email:
Principal Investigator
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Steven Kao
Email:
Principal Investigator
Facility:
Name:
Peninsula and South East Oncology
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Vinod Ganju
Email:
Principal Investigator
Facility:
Name:
University Health Network, Princess Margaret Hospital
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Amit Oza, MD
Email:
Principal Investigator
Facility:
Name:
McGill University Department of Oncology / McGill University Health Centre
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Lucy Gilbert
Email:
Principal Investigator
Facility:
Name:
CHU de Quebec-Universite Laval
Address:
City:
Quebec
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Vincent Castonguay
Email:
Principal Investigator
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Ki Hyeong Lee
Email:
Principal Investigator
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Joo Hwan Park, MD
Email:
Principal Investigator
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Seongnam
Zip:
13496
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Joo-Hang Kim
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Sung Bae Kim
Email:
Principal Investigator
Facility:
Name:
Sungkyunkwan University of Medicine - Samsung Changwon Hospital
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Se Hoon Lee
Email:
Principal Investigator
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Maria Martinez Garcia
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Reina Sofia
Address:
City:
Cordoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Rosa Maria Rodriguez Alonso
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Antonio Gonzalez Martin, MD
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Antonio Gonzalez Martin, MD
Email:
Principal Investigator
Facility:
Name:
The Royal Marsden NHS Foundation Trust (RM)
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Susana Banerjee
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital Sutton
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Susana Banerjee
Email:
Principal Investigator
Start date:
November 14, 2023
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06003231
