Back to resultsA Study of SGN-B7H4V in Advanced Solid Tumors
Primary Purpose
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SGN-B7H4V
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms focused on measuring High-grade serous epithelial ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, HER2-negative breast cancer, HR positive breast cancer, Triple-negative breast cancer, TNBC, Endometrial carcinoma, Non-small cell lung cancer, NSCLC, SqCC, AC, ACC of the head and neck, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:
- High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- HER2-negative, HR positive breast cancer
- Triple-negative breast cancer (TNBC)
- Endometrial carcinoma
- Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])
- Cholangiocarcinoma or gallbladder carcinoma
- Adenoid cystic carcinoma (ACC) of the head and neck
- Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option
- Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, unless contraindicated
- Tumor tissue is required for enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease per RECIST version 1.1 at baseline
Exclusion Criteria:
- History of another malignancy within 3 years before the first dose of study drug. Any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
- are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
- have no new or enlarging brain metastases
- and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.
- Carcinomatous meningitis
- Previous receipt of an MMAE-containing agent or an agent targeting B7-H4
- Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
- Corneal disease or injury requiring treatment or active monitoring
Sites / Locations
- University of Colorado Hospital / University of ColoradoRecruiting
- Sarah Cannon Research Institute at HealthONE - DenverRecruiting
- AdventHealth Cancer InstituteRecruiting
- Mayo Clinic FloridaRecruiting
- Florida Cancer Specialists - Lake NonaRecruiting
- Northwestern UniversityRecruiting
- Community Health NetworkRecruiting
- South Texas Accelerated Research Therapeutics MidwestRecruiting
- Tennessee Oncology-Nashville/Sarah Cannon Research InstituteRecruiting
- MD Anderson Cancer Center / University of TexasRecruiting
- South Texas Accelerated Research TherapeuticsRecruiting
- South Texas Accelerated Research Therapeutics Mountain RegionRecruiting
- University of Ottawa / Ottawa General HospitalRecruiting
- Charite Universitatsmedizin BerlinRecruiting
- Instituto Europeo di OncologiaRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- START Madrid-CIOCC_Hospital HM SanchinarroRecruiting
- Sarah Cannon Research Institute UKRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-B7H4V
Arm Description
SGN-B7H4V monotherapy
Outcomes
Primary Outcome Measures
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities
Number of participants with dose limiting toxicities (DLTs)
Secondary Outcome Measures
Objective response rate (ORR)
The proportion of participants achieving a partial response (PR), or complete response (CR) as assessed by the investigator per RECIST Version 1.1.
Complete response rate (CRR)
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
Duration of response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.
Progression-free survival (PFS)
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Overall survival (OS)
The time from the start of any study treatment to the date of death due to any cause.
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics.
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics.
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics.
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics.
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics.
Incidence of antidrug antibodies (ADAs)
To be summarized using descriptive statistics.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05194072
Brief Title
A Study of SGN-B7H4V in Advanced Solid Tumors
Official Title
A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
January 31, 2027 (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 study will test the safety of a drug called SGN-B7H4V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.
Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms, HER2 Negative Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Gallbladder Carcinoma, Adenoid Cystic Carcinoma
Keywords
High-grade serous epithelial ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, HER2-negative breast cancer, HR positive breast cancer, Triple-negative breast cancer, TNBC, Endometrial carcinoma, Non-small cell lung cancer, NSCLC, SqCC, AC, ACC of the head and neck, Seattle Genetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGN-B7H4V
Arm Type
Experimental
Arm Description
SGN-B7H4V monotherapy
Intervention Type
Drug
Intervention Name(s)
SGN-B7H4V
Intervention Description
Given into the vein (IV; intravenously)
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Through 30 days after last study treatment, up to approximately 3 years
Title
Number of participants with laboratory abnormalities
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Title
Number of participants with dose limiting toxicities (DLTs)
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The proportion of participants achieving a partial response (PR), or complete response (CR) as assessed by the investigator per RECIST Version 1.1.
Time Frame
Up to approximately 3 years
Title
Complete response rate (CRR)
Description
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
Time Frame
Up to approximately 3 years
Title
Duration of response (DOR)
Description
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.
Time Frame
Up to approximately 3 years
Title
Progression-free survival (PFS)
Description
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Time Frame
Up to approximately 3 years
Title
Overall survival (OS)
Description
The time from the start of any study treatment to the date of death due to any cause.
Time Frame
Up to approximately 3 years
Title
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Title
PK parameter - Maximum concentration (Cmax)
Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Title
PK parameter - Time to maximum concentration (Tmax)
Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Title
PK parameter - Apparent terminal half-life (t1/2)
Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Title
PK parameter - Trough concentration (Ctrough)
Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
Title
Incidence of antidrug antibodies (ADAs)
Description
To be summarized using descriptive statistics.
Time Frame
Through 30-37 days after last study treatment, up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:
High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
HER2-negative, HR positive breast cancer
Triple-negative breast cancer (TNBC)
Endometrial carcinoma
Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])
Cholangiocarcinoma or gallbladder carcinoma
Adenoid cystic carcinoma (ACC) of the head and neck
Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option
Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, unless contraindicated
Tumor tissue is required for enrollment.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease per RECIST version 1.1 at baseline
Exclusion Criteria:
History of another malignancy within 3 years before the first dose of study drug. Any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
have no new or enlarging brain metastases
and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.
Carcinomatous meningitis
Previous receipt of an MMAE-containing agent or an agent targeting B7-H4
Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Corneal disease or injury requiring treatment or active monitoring
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
Natalya Nazarenko, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Hospital / University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Gasparro
Phone
720-848-9353
First Name & Middle Initial & Last Name & Degree
Jennifer Diamond
Facility Name
Sarah Cannon Research Institute at HealthONE - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Kirk
Phone
720-754-2610
Email
Sarah.Kirk@SarahCannon.com
First Name & Middle Initial & Last Name & Degree
Jason Henry
Facility Name
AdventHealth Cancer Institute
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guru Sonpavde
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivy Vilches
Phone
904-953-7844
Email
Vilches.ivyanne@mayo.edu
First Name & Middle Initial & Last Name & Degree
Gerardo Colon-Otero
Facility Name
Florida Cancer Specialists - Lake Nona
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Griffith
Phone
689-216-8500
Email
Elizabeth.Griffith@scri.com
First Name & Middle Initial & Last Name & Degree
Cesar Perez Batista, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Northwestern University CT.Gov Contact
Phone
312-695-1301
First Name & Middle Initial & Last Name & Degree
Aparna Kalyan, MBBS
Facility Name
Community Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Byers
Email
abyers2@ecommunity.com
First Name & Middle Initial & Last Name & Degree
Bert H O'Neil
Facility Name
South Texas Accelerated Research Therapeutics Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Fabrie
Phone
616-954-5559
First Name & Middle Initial & Last Name & Degree
Nehal Lakhani, MD, PhD
Facility Name
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Autumn Teal
Phone
615-946-0592
Email
Autumn.Teal@SCRI.com
First Name & Middle Initial & Last Name & Degree
Erika P Hamilton
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Ferrarotto
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Jimenez
Phone
210-593-5265
Email
isabel.jimenez@startsa.com
First Name & Middle Initial & Last Name & Degree
Amita Patnaik
Facility Name
South Texas Accelerated Research Therapeutics Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Larsen
Phone
801-907-4752
First Name & Middle Initial & Last Name & Degree
Justin Call
Facility Name
University of Ottawa / Ottawa General Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arif Awan
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
State/Province
Other
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonia Busse
Facility Name
Instituto Europeo di Oncologia
City
Milano
State/Province
Other
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Curigliano
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Other
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Garralda Cabanas
Facility Name
START Madrid-CIOCC_Hospital HM Sanchinarro
City
Madrid
State/Province
Other
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Moreno Candilejo
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Other
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Fontana
12. IPD Sharing Statement
Learn more about this trial
A Study of SGN-B7H4V in Advanced Solid Tumors
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