Breast Cancer Clinical Trial

A Study of SGN-B7H4V in Advanced Solid Tumors

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.

View Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

430

Study ID:

NCT05194072

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 19 Locations for this study

See Locations Near You

University of Colorado Hospital / University of Colorado
Aurora Colorado, 80045, United States More Info
Brandi Asheim
Contact
[email protected]
Jennifer Diamond
Principal Investigator
Sarah Cannon Research Institute at HealthONE - Denver
Denver Colorado, 80218, United States More Info
Jason Henry
Principal Investigator
AdventHealth Cancer Institute
Celebration Florida, 34747, United States More Info
Charmaine Garcia
Contact
407-303-4471
[email protected]
Guru Sonpavde
Principal Investigator
Mayo Clinic Florida
Jacksonville Florida, 32224, United States More Info
Gerardo Colon-Otero
Principal Investigator
Florida Cancer Specialists - Lake Nona
Orlando Florida, 32827, United States More Info
Cesar Perez Batista, MD
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Northwestern University CT.Gov Contact
Contact
312-695-1301
Aparna Kalyan, MBBS
Principal Investigator
Community Health Network
Indianapolis Indiana, 46250, United States More Info
Adam Byers
Contact
[email protected]
Bert H O'Neil
Principal Investigator
South Texas Accelerated Research Therapeutics Midwest
Grand Rapids Michigan, 49546, United States More Info
Shannon Fabrie
Contact
616-954-5559
Nehal Lakhani, MD, PhD
Principal Investigator
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Melanie Hurst
Contact
615-979-9868
Erika P Hamilton
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Amanda Drews
Contact
832-834-1573
Renata Ferrarotto
Principal Investigator
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States More Info
Isabel Jimenez
Contact
210-593-5265
[email protected]
Amita Patnaik
Principal Investigator
South Texas Accelerated Research Therapeutics Mountain Region
West Valley City Utah, 84119, United States More Info
Casey Larsen
Contact
801-907-4752
Justin Call
Principal Investigator
University of Ottawa / Ottawa General Hospital
Ottawa Ontario, K1H 8, Canada More Info
Arif Awan
Principal Investigator
McGill University Department of Oncology / McGill University Health Centre
Montreal Quebec, H4A 3, Canada More Info
Victoria Mandilaras
Principal Investigator
Charite Universitatsmedizin Berlin
Berlin Other, 10117, Germany More Info
Antonia Busse
Principal Investigator
Instituto Europeo di Oncologia
Milano Other, 20132, Italy More Info
Giuseppe Curigliano
Principal Investigator
Hospital Universitari Vall d'Hebron
Barcelona Other, 08035, Spain More Info
Elena Garralda Cabanas
Principal Investigator
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid Other, 28050, Spain More Info
Irene Moreno Candilejo
Principal Investigator
Sarah Cannon Research Institute UK
London Other, W1G 6, United Kingdom More Info
Elisa Fontana
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

430

Study ID:

NCT05194072

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

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