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).

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)
Part A only: 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 options.
Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available.
Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or [neo]adjuvant therapy is allowed).
Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.

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 (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.
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 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts

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 sigvotatug vedotin.

Routine antimicrobial prophylaxis is permitted
Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses
Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).
History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening
Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) <50% predicted

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

824

Study ID:

NCT04389632

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 21 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
Alisa Posner
Contact
617-975-7423
[email protected]
Bruno Bockorny, MD
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Illya Dixon
Contact
617-632-5084
[email protected]
Kartik Sehgal
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States More Info
Edwin C Kingsley
Contact
702-952-3400
[email protected]
Edwin C Kingsley
Principal Investigator
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Megan Boland
Contact
216-286-3379
[email protected]
Afshin Dowlati
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Providence Cancer Institute CT.Gov Contact
Contact
503-215-2614
[email protected]
Rachel E Sanborn
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97225, United States More Info
Rachel E Sanborn
Principal Investigator
Sanford Cancer Center
Sioux Falls South Dakota, 57104, United States More Info
Staci Vogel
Contact
605-328-8000
[email protected]
Steven Powell
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Rabia Khan
Contact
713-745-4667
[email protected]
Sarina A Piha-Paul
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
Vista Oncology Inc PS
Olympia Washington, 98506, United States More Info
Yiqun (Lydia) Xue
Contact
360-810-3619
[email protected]
Joseph Z Ye
Principal Investigator
Institut Gustave Roussy
Villejuif Cedex Other, 94805, France More Info
Antoine Hollebecque
Principal Investigator
Hospital HM Nou Delfos
Barcelona Other, 08023, Spain More Info
Tatiana Carolina Hernandez Guerrero
Principal Investigator
Hospital Universitari Vall d'Hebron
Barcelona Other, 08035, Spain More Info
Elena Garralda Cabanas
Principal Investigator
Elche General University Hospital
Elche Other, 03203, Spain More Info
Alvaro Rodriguez Lescure
Principal Investigator
Hospital Universitario De Jerez
Jerez de la Frontera Other, 11407, Spain More Info
Jesus Corral
Principal Investigator
Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos
Madrid Other, 28034, Spain More Info
Federico Longo
Principal Investigator
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid Other, 28050, Spain More Info
Emiliano Calvo
Principal Investigator
Hospital Universitario Marques de Valdecilla
Santander Other, 39008, Spain More Info
Fernando Rivera Herrero
Principal Investigator
University Hospital Lausanne CHUV
Lausanne Other, 1011, Switzerland More Info
Solange Peters
Principal Investigator
Sarah Cannon Research Institute UK
London Other, W1G 6, United Kingdom More Info
Elisa Fontana
Principal Investigator
The Royal Marsden Hospital (Surrey)
Sutton Other, 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:

824

Study ID:

NCT04389632

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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