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) 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

375

Study ID:

NCT05194072

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 11 Locations for this study

See Locations Near You

University of Colorado Hospital / University of Colorado
Aurora Colorado, 80045, United States More Info
Kassidy Cleland
Contact
720-848-1234
[email protected]
Jennifer Diamond
Principal Investigator
Sarah Cannon Research Institute at HealthONE - Denver
Denver Colorado, 80218, United States More Info
Sarah Kirk
Contact
720-754-2610
[email protected]
Jason Henry
Principal Investigator
AdventHealth Cancer Institute
Celebration Florida, 34747, United States More Info
Guru Sonpavde
Principal Investigator
Mayo Clinic Florida
Jacksonville Florida, 32224, United States More Info
Ivy Vilches
Contact
904-953-7844
[email protected]
Gerardo Colon-Otero
Principal Investigator
Florida Cancer Specialists - Lake Nona
Orlando Florida, 32827, United States More Info
Elizabeth Griffith
Contact
689-216-8500
[email protected]
Cesar Perez Batista
Principal Investigator
Community Health Network
Indianapolis Indiana, 46250, United States More Info
Adam Byers
Contact
[email protected]
Bert O'Neil
Principal Investigator
South Texas Accelerated Research Therapeutics Midwest
Grand Rapids Michigan, 49546, United States More Info
Katie Robinson
Contact
616-389-1739
[email protected]
Nehal Lakhani
Principal Investigator
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Autumn Teal
Contact
615-946-0592
[email protected]
Erika Hamilton
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
[email protected]
Justin Call
Principal Investigator
START Madrid-CIOCC Hospital HM Sanchinarro
Madrid Other, 28050, Spain More Info
Irene Moreno
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

375

Study ID:

NCT05194072

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

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