Recruiting
Phase 1

SGN-B6A

Sponsor:

Seagen, a wholly owned subsidiary of Pfizer

Code:

NCT04389632

Conditions

Carcinoma, Non-Small Cell Lung

Squamous Cell Carcinoma of Head and Neck

HER2 Negative Breast Neoplasms

Esophageal Squamous Cell Carcinoma

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

sigvotatug vedotin

pembrolizumab

cisplatin

carboplatin

Study Details

Brief summary:

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

  • Part A of the study will find out how much sigvotatug vedotin should be given to participants.
  • Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.
  • Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.
  • Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.
  • In Parts C and D, participants will receive sigvotatug vedotin with either:

  • Pembrolizumab or,
  • Pembrolizumab and carboplatin, or
  • Pembrolizumab and cisplatin.

Conditions

Carcinoma, Non-Small Cell Lung

Squamous Cell Carcinoma of Head and Neck

HER2 Negative Breast Neoplasms

Esophageal Squamous Cell Carcinoma

Esophageal Adenocarcinoma

Study ID

NCT04389632

Start date

Jun 8, 2020

Status verified date

Jul, 2026

Completion date

Mar 22, 2029

Anticipated

Primary completion date

Jun 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.
  • 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
  • Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study Design

Enrollment

1006 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Dose escalation

sigvotatug vedotin monotherapy

experimental: Part B: Dose expansion

sigvotatug vedotin monotherapy

experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLC

sigvotatug vedotin + pembrolizumab +/- (carboplatin)

experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCC

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

Interventions

sigvotatug vedotin

Administered into the vein (IV; intravenously)

pembrolizumab

200mg every 3 weeks or 400mg every 6 weeks, given by IV

cisplatin

75 mg/m2 every 3 weeks, given by IV

carboplatin

AUC 5 mg/mL per min every 3 weeks, given by IV

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years ]
  • Number of patients with laboratory abnormalities [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years ]
  • Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Alaska Oncology and Hematology

Recruiting

Anchorage, Alaska, United States, 99508

Highlands Oncology Group

Recruiting

Fayetteville, Arkansas, United States, 72703

Highlands Oncology Group

Recruiting

Rogers, Arkansas, United States, 72758

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Providence Medical Foundation

Recruiting

Anaheim, California, United States, 92805

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Providence St. Jude Medical Center Virginia K Crosson and Infusion Center

Recruiting

Fullerton, California, United States, 92835

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

The Regents of the University of California

Recruiting

Los Angeles, California, United States, 90095

UCLA Department of Medicine-Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90095

UCLA Department of Medicine - Hematology & Oncology

Recruiting

Santa Monica, California, United States, 90404

American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology

Recruiting

Fort Myers, Florida, United States, 33913

Florida Cancer Specialists & Research Institute, LLC

Recruiting

Fort Myers, Florida, United States, 33916

Memorial Cancer Institute

Recruiting

Hollywood, Florida, United States, 33021

Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Memorial Cancer Institute at Memorial Hospital West

Recruiting

Pembroke Pines, Florida, United States, 33028

Memorial Hospital West

Recruiting

Pembroke Pines, Florida, United States, 33028

Ingalls Family Care Center

Recruiting

Calumet City, Illinois, United States, 60409

UChicago Medicine - River East

Recruiting

Chicago, Illinois, United States, 60611

The University Of Chicago

Recruiting

Chicago, Illinois, United States, 60637

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

UChicago Medicine at Ingalls - Flossmoor

Recruiting

Flossmoor, Illinois, United States, 60422

UChicago Medicine Ingalls Memorial

Recruiting

Harvey, Illinois, United States, 60426

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

Recruiting

New Lenox, Illinois, United States, 60451

The University of Chicago Medicine Center for Advanced Care Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Southern Illinois University - Simmons Cancer Institute

Recruiting

Springfield, Illinois, United States, 62702

Springfield Clinic Radiology - 800 Building

Recruiting

Springfield, Illinois, United States, 62702

Springfield Clinic Urgent Care Plus

Recruiting

Springfield, Illinois, United States, 62702

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Springfield Clinic Main Campus

Recruiting

Springfield, Illinois, United States, 62703

Springfield Clinic Radiology - Main Campus

Recruiting

Springfield, Illinois, United States, 62703

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

UChicago Medicine at Ingalls - Tinley Park

Recruiting

Tinley Park, Illinois, United States, 60477

UChicago Medicine - Northwest Indiana

Recruiting

Crown Point, Indiana, United States, 46307

Fort Wayne Medical Oncology and Hematology, Inc

Recruiting

Fort Wayne, Indiana, United States, 46804

Community Health Network, Inc

Recruiting

Indianapolis, Indiana, United States, 46219

Community Health Network, Inc.

Recruiting

Indianapolis, Indiana, United States, 46227

Community Health Network Investigational Drug Services

Recruiting

Indianapolis, Indiana, United States, 46250

Community Health Network, Inc.

Recruiting

Indianapolis, Indiana, United States, 46250

The University of Kansas Cancer Center, Investigational Drug Services

Recruiting

Fairway, Kansas, United States, 66205

The University of Kansas Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

The University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Medical Center Medical Office Building

Recruiting

Kansas City, Kansas, United States, 66160

University of Kansas Hospital Cambridge North Tower A

Recruiting

Kansas City, Kansas, United States, 66160

University of Kansas Medical Center Research Institute

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Cancer Center - Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

The University of Kansas Cancer Center - Westwood

Recruiting

Westwood, Kansas, United States, 66205

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Beth Israel Deaconess Medical Center,East Campus Research Pharmacy

Recruiting

Boston, Massachusetts, United States, 02215

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute - Chestnut Hill

Recruiting

Newton, Massachusetts, United States, 02467

Allina Health Cancer Institute - Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Allina Health Cancer Institute - Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Allina Health Cancer Institute - United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Allina Health Cancer Institute

Recruiting

Saint Paul, Minnesota, United States, 55102

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89169

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Babylon, New York, United States, 11702

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Brooklyn, New York, United States, 11210

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

New Hyde Park, New York, United States, 11042

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

New York, New York, United States, 10028

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Patchogue, New York, United States, 11772

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Port Jefferson Station, New York, United States, 11776

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Riverhead, New York, United States, 11901

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

The Bronx, New York, United States, 10469

OU Health University of Oklahoma Medical Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Stephenson Cancer Center (chemo location)

Recruiting

Oklahoma City, Oklahoma, United States, 73104

University of Oklahoma Health Science Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Providence Cancer Institute Franz Clinic

Recruiting

Portland, Oregon, United States, 97213

Providence Oncology and Hematology Care Clinic - Westside

Recruiting

Portland, Oregon, United States, 97225

Providence St. Vincent Medical Center- Investigational Drug Services

Recruiting

Portland, Oregon, United States, 97225

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Sanford Cancer Center

Recruiting

Sioux Falls, South Dakota, United States, 57104

Sanford USD Medical Center

Recruiting

Sioux Falls, South Dakota, United States, 57105

US Oncology Research LLC

Recruiting

Nashville, Tennessee, United States, 37203

Oncology Consultants, PA

Recruiting

Houston, Texas, United States, 77024

Oncology Consultants, PA.

Recruiting

Houston, Texas, United States, 77030

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

US Oncology Investigational Product Center (IPC)

Recruiting

Irving, Texas, United States, 75063

UT Health East Texas HOPE Cancer Center

Recruiting

Tyler, Texas, United States, 75701

UT Health East Texas Hope Cancer Center

Recruiting

Tyler, Texas, United States, 75708

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Swedish Cancer Institute - Edmonds Campus

Recruiting

Edmonds, Washington, United States, 98026

Swedish Cancer Institute Edmonds Campus

Recruiting

Edmonds, Washington, United States, 98026

American Oncology Network Vista Oncology Division-West office

Recruiting

Olympia, Washington, United States, 98502

American Oncology Network Vista Oncology Division-East office

Recruiting

Olympia, Washington, United States, 98506

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Exigent Research, LLC

Recruiting

Tacoma, Washington, United States, 98405

More Information

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • NSCLC
  • HNSCC
  • cSCC
  • ESCC
  • EAC
  • GEJ
  • HGSOC
  • Advanced HER2-Negative Breast Cancer
  • High Grade Serous Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Head and Neck Squamous Cell Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Cervical Cancer
  • Gastric Cancer
  • Seattle Genetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Seagen, a wholly owned subsidiary of Pfizer on 2026-07-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.