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

Primary Purpose

Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
disitamab vedotin
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell of Head and Neck focused on measuring HNSCC, NSCLC, Ovarian Cancer, Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cohort 1: 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: 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 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. Previous treatment with HER2-directed ADCs 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

Sites / Locations

  • Providence Medical FoundationRecruiting
  • Eastern CT Hematology and Oncology AssociatesRecruiting
  • St. Vincent Frontier Cancer CenterRecruiting
  • NYU Langone HospitalRecruiting
  • NYU Langone HospitalRecruiting
  • Gabrail Cancer Center Research, LLCRecruiting
  • Renovatio ClinicalRecruiting
  • MD Anderson Cancer Center / University of TexasRecruiting
  • Renovatio ClinicalRecruiting
  • CHU de Quebec-Universite LavalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Disitamab vedotin monotherapy

Arm Description

Disitamab vedotin monotherapy

Outcomes

Primary Outcome Measures

Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator

Secondary Outcome Measures

Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Number of participants with laboratories abnormalities
Number of participants with dose alterations due to AEs
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Duration of Progression Free Survival (PFS) per RECIST v1.1 by investigator assessment
The time from the start of study treatment to the first documentation of disease progression per RECIST v1.1 or death due to any cause
Overall Survival (OS)
The time from the start of study treatment to the date of death due to any cause
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Analyzed through cycle 2.
PK parameter - Maximum concentration (Cmax)
Analyzed through end of treatment.
PK parameter - Trough concentration (Ctrough)
Analyzed through end of treatment.
Incidence of antidrug antibodies (ADAs)

Full Information

First Posted
August 15, 2023
Last Updated
October 23, 2023
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06003231
Brief Title
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
Official Title
A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Endometrial Neoplasms
Keywords
HNSCC, NSCLC, Ovarian Cancer, Endometrial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Disitamab vedotin monotherapy
Arm Type
Experimental
Arm Description
Disitamab vedotin monotherapy
Intervention Type
Drug
Intervention Name(s)
disitamab vedotin
Other Intervention Name(s)
RC48, RC48-ADC
Intervention Description
Given into the vein (IV, intravenous) every 2 weeks
Primary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Description
The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Time Frame
Approximately 3 years
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Time Frame
Through 30-37 days after the last dose of DV; approximately 5 years
Title
Number of participants with laboratories abnormalities
Time Frame
Through 30-37 days after the last dose of DV; approximately 5 years
Title
Number of participants with dose alterations due to AEs
Time Frame
Approximately 5 years
Title
Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
Description
The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
Time Frame
Approximately 5 years
Title
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
Description
The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Time Frame
Approximately 5 years
Title
Duration of Progression Free Survival (PFS) per RECIST v1.1 by investigator assessment
Description
The time from the start of study treatment to the first documentation of disease progression per RECIST v1.1 or death due to any cause
Time Frame
Approximately 5 years
Title
Overall Survival (OS)
Description
The time from the start of study treatment to the date of death due to any cause
Time Frame
Approximately 5 years
Title
Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Description
Analyzed through cycle 2.
Time Frame
Approximately 1 month
Title
PK parameter - Maximum concentration (Cmax)
Description
Analyzed through end of treatment.
Time Frame
Through 30-37 days after the last dose of DV; approximately 5 years
Title
PK parameter - Trough concentration (Ctrough)
Description
Analyzed through end of treatment.
Time Frame
Through 30-37 days after the last dose of DV; approximately 5 years
Title
Incidence of antidrug antibodies (ADAs)
Time Frame
Through 30-37 days after the last dose of DV; approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cohort 1: 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: 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 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. Previous treatment with HER2-directed ADCs 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seagen Trial Information Support
Phone
866-333-7436
Email
clinicaltrials@seagen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuemei Li
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Shaffer
Phone
707-521-3809
First Name & Middle Initial & Last Name & Degree
Ian C Anderson
Facility Name
Eastern CT Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Wilcox
Phone
860-886-8362
Email
nwilcox@echoct.com
First Name & Middle Initial & Last Name & Degree
Dennis Slater
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Stonebraker
Email
Ali.Stonebraker@imail.org
First Name & Middle Initial & Last Name & Degree
Patrick Cobb
Facility Name
NYU Langone Hospital
City
N. New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavana Pothuri
Facility Name
NYU Langone Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavana Pothuri
Facility Name
Gabrail Cancer Center Research, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Rich
Phone
330-492-3345
Email
arich@gabrailcancercenter.com
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail
Facility Name
Renovatio Clinical
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maritza Seanez
Phone
713-703-2398
Email
maritza.seanez@renovatioclinical.com
First Name & Middle Initial & Last Name & Degree
Haroutioun Shahinian
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ecaterina E Ileana-Dumbrava
Facility Name
Renovatio Clinical
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Villarreal
Phone
713-703-2398
First Name & Middle Initial & Last Name & Degree
Jonathan Lu
Facility Name
CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Castonguay

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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