A Study of SGN-B7H4V in Advanced Solid Tumors

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Description

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.

Study Overview

Start Date
January 12, 2022
Completion Date
January 31, 2027
Enrollment
430
Date Posted
January 18, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
University of Colorado Hospital / University of Colorado
Aurora, Colorado 80045, United States

Sarah Cannon Research Institute at HealthONE - Denver
Denver, Colorado 80218, United States

AdventHealth Cancer Institute
Celebration, Florida 34747, United States

Mayo Clinic Florida
Jacksonville, Florida 32224, United States

Florida Cancer Specialists - Lake Nona
Orlando, Florida 32827, United States

Northwestern University
Chicago, Illinois 60611, United States

Community Health Network
Indianapolis, Indiana 46250, United States

South Texas Accelerated Research Therapeutics Midwest
Grand Rapids, Michigan 49546, United States

Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee 37203, United States

MD Anderson Cancer Center / University of Texas
Houston, Texas 77030, United States

South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229, United States

South Texas Accelerated Research Therapeutics Mountain Region
West Valley City, Utah 84119, United States

University of Ottawa / Ottawa General Hospital
Ottawa, Ontario K1H 8L6, Canada

Charite Universitatsmedizin Berlin
Berlin, Other 10117, Germany

Instituto Europeo di Oncologia
Milano, Other 20132, Italy

Hospital Universitari Vall d'Hebron
Barcelona, Other 08035, Spain

START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid, Other 28050, Spain

Sarah Cannon Research Institute UK
London, Other W1G 6AD, United Kingdom

Eligibility

Minimum Age (years)
18
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)
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

Study Contact Info

Study Contact Name
Seagen Trial Information Support
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05194072