Breast Cancer Clinical Trial

A Study of SGN-B6A in Advanced Solid Tumors

Summary

This trial will look at a drug called SGN-B6A to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Disease indication

Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part). Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic option.
Non-small cell lung cancer (NSCLC)
Head and neck squamous cell cancer (HNSCC)
Advanced HER2-negative breast cancer
Esophageal squamous cell carcinoma (ESCC)
Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)
Cutaneous squamous cell cancer (cSCC)
Exocrine pancreatic adenocarcinoma
Bladder cancer
Cervical cancer
Gastric cancer
High grade serous ovarian cancer (HGSOC)

Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:

Disease-specific expansion cohorts, participant 16 onwards: pretreatment biopsy
Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy
An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease per the RECIST v1.1 at baseline

Exclusion Criteria

History of another malignancy within 3 years before first dose of study drug, or 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 of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
Carcinomatous meningitis
Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6
Pre-existing neuropathy Grade 2 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)

Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-B6A.

Routine antimicrobial prophylaxis is permitted

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

355

Study ID:

NCT04389632

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 12 Locations for this study

See Locations Near You

Florida Cancer Specialists - Lake Nona
Orlando Florida, 32827, United States More Info
Ingrid Acker
Contact
689-216-8500
[email protected]
Cesar Perez Batista, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
Taylor Burns
Contact
[email protected]
Bruno Bockorny
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Mary Liebers
Contact
[email protected]
Illya Dixon
Contact
[email protected]
Kartik Sehgal
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States More Info
Edwin Kingsley
Contact
[email protected]
Edwin Kingsley
Principal Investigator
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Megan Magdinec
Contact
[email protected]
Afshin Dowlati
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Providence Cancer Institute
Contact
[email protected]
Rachel Sanborn
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Rabia Khan
Contact
[email protected]
Sarina Piha-Paul
Principal Investigator
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States More Info
Isabel Jimenez
Contact
[email protected]
Amita Patnaik
Principal Investigator
Institut Gustave Roussy
Villejuif Cedex , 94805, France More Info
Antoine Hollebecque
Principal Investigator
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain More Info
Elena Garralda Cabanas
Principal Investigator
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain More Info
Emiliano Calvo
Principal Investigator
University Hospital Lausanne CHUV
Lausanne , 1011, Switzerland More Info
Solange Peters
Principal Investigator
The Royal Marsden Hospital (Surrey)
Sutton , SM2 5, United Kingdom More Info
Juanita Lopez
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

355

Study ID:

NCT04389632

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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