Ovarian Cancer Clinical Trial

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT06003231

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 30 Locations for this study

See Locations Near You

Ironwood Cancer & Research Centers - Chandler
Chandler Arizona, 85224, United States More Info
Devanie Heisler
Contact
480-792-6033 x20195
Sujith R Kalmadi
Principal Investigator
Valkyrie Clinical Trials
Los Angeles California, 90067, United States More Info
Chemyn Cortez
Contact
559-360-3707
[email protected]
David Berz
Principal Investigator
University of California Davis
Sacramento California, 95817, United States More Info
Snoti Kumeh
Contact
916-734-3608
[email protected]
Jonathan W Riess
Principal Investigator
Providence Medical Foundation
Santa Rosa California, 95403, United States More Info
Camille Shaffer
Contact
707-521-3809
Ian C Anderson
Principal Investigator
Colorado West Healthcare, dba Grand Valley Oncology
Grand Junction Colorado, 81505, United States More Info
Clinical Trial General Email
Contact
970-644-4460
[email protected]
Jonathan King
Principal Investigator
Yale Cancer Center
New Haven Connecticut, 06511, United States More Info
Karen Rodriguez Seely
Contact
203-314-3303
[email protected]
So Yeon Kim
Principal Investigator
Eastern CT Hematology and Oncology Associates
Norwich Connecticut, 06360, United States More Info
Nancy Wilcox
Contact
860-886-8362
[email protected]
Dennis Slater
Principal Investigator
University of Miami
Miami Florida, 33136, United States More Info
Patricia Rozas
Contact
305-243-5601
[email protected]
Matthew Schlumbrecht
Principal Investigator
Augusta University
Augusta Georgia, 30912, United States More Info
Donna Wheatley
Contact
706-721-8978
[email protected]
Sharad Ghamande
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Joyce Liu
Contact
877-338-7425
[email protected]
Joyce Liu
Principal Investigator
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48201, United States More Info
Allison Wolgast
Contact
313-576-8994
[email protected]
Ammar Sukari
Principal Investigator
HealthPartners Institute
Saint Louis Park Minnesota, 55426, United States More Info
Hannah Merrill
Contact
952-993-0996
[email protected]
Yan Ji
Principal Investigator
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States More Info
Ali Stonebraker
Contact
[email protected]
Patrick Cobb
Principal Investigator
Optimum Clinical Research Group, LLC (Southwest Women's Oncology)
Albuquerque New Mexico, 87109, United States More Info
Milena Overby
Contact
505-372-4270
[email protected]
Karen Finkelstein
Principal Investigator
NYU Langone Hospital
Mineola New York, 11501, United States More Info
Karen Estok
Contact
212-404-4434
Bhavana Pothuri
Principal Investigator
NYU Langone Hospital
New York New York, 10016, United States More Info
Anika Tasnim
Contact
[email protected]
Bhavana Pothuri
Principal Investigator
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Hollie Watson
Contact
919-681-3466
[email protected]
Niharika Mettu
Principal Investigator
Gabrail Cancer Center Research, LLC
Canton Ohio, 44718, United States More Info
Amanda Rich
Contact
330-492-3345
[email protected]
Nashat Gabrail
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Kim Sutcliffe
Contact
503-215-5763
[email protected]
Rachel E Sanborn
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97225, United States More Info
Kim Sutcliffe
Contact
503-215-5763
[email protected]
Rachel E Sanborn
Principal Investigator
Renovatio Clinical
El Paso Texas, 79915, United States More Info
Maritza Seanez
Contact
713-703-2398
[email protected]
Haroutioun Shahinian
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Sally McGahee
Contact
832-507-3548
[email protected]
Ecaterina E Ileana-Dumbrava
Principal Investigator
Renovatio Clinical
The Woodlands Texas, 77380, United States More Info
Pablo Villarreal
Contact
713-703-2398
Jonathan Lu
Principal Investigator
Fred Hutchinson Cancer Research Center | Seattle, WA
Seattle Washington, 98109, United States More Info
Rebecca Wood
Contact
206-606-2936
[email protected]
Diane Tseng, MD
Principal Investigator
Blacktown Hospital
Blacktown NSW Other, 2148, Australia More Info
Bo Gao
Principal Investigator
Macquarie University Hospital
Brisbane Other, 2109, Australia More Info
John Park
Principal Investigator
Peninsula and South East Oncology
Frankston Other, 3199, Australia More Info
Vinod Ganju
Principal Investigator
University Health Network, Princess Margaret Hospital
Toronto Ontario, M5G 1, Canada More Info
Amit Oza, MD
Principal Investigator
McGill University Department of Oncology / McGill University Health Centre
Montreal Quebec, H4A 3, Canada More Info
Lucy Gilbert
Principal Investigator
CHU de Quebec-Universite Laval
Quebec , G1J 1, Canada More Info
Vincent Castonguay
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT06003231

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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