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AzTrials

Carcinoma, Non-Small Cell LungPhase 1NCT04389632

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

A Phase 1 study testing sigvotatug vedotin, pembrolizumab and cisplatin in people with Carcinoma, Non-Small Cell Lung and Squamous Cell Carcinoma of Head and Neck, run by Seagen, a wholly owned subsidiary of Pfizer at 158 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sigvotatug vedotin, pembrolizumab and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,006 participants
Where
158 sitesin 7 countries
Study dates
8 Jun 2020to 22 Mar 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

158 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

158 sites in 7 countries

United States106 sites, 104 recruiting

  • Providence Medical Foundation

    Anaheim, California, 92805

    Recruiting

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508

    Recruiting

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

    Babylon, New York, 11702

    Recruiting

  • Northwest Medical Specialities. PLLC

    Bonney Lake, Washington, 98391

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Beth Israel Deaconess Medical Center,East Campus Research Pharmacy

    Boston, Massachusetts, 02215

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

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

    Brooklyn, New York, 11210

    Recruiting

  • Ingalls Family Care Center

    Calumet City, Illinois, 60409

    Recruiting

  • UChicago Medicine - River East

    Chicago, Illinois, 60611

    Recruiting

  • The University Of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Active, not recruiting

  • Allina Health Cancer Institute - Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Recruiting

  • UChicago Medicine - Northwest Indiana

    Crown Point, Indiana, 46307

    Recruiting

  • Swedish Cancer Institute - Edmonds Campus

    Edmonds, Washington, 98026

    Recruiting

  • Swedish Cancer Institute Edmonds Campus

    Edmonds, Washington, 98026

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • The University of Kansas Cancer Center, Investigational Drug Services

    Fairway, Kansas, 66205

    Recruiting

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

    Recruiting

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

    Recruiting

  • Northwest Medical Specialities.PLLC

    Federal Way, Washington, 98003

    Not yet recruiting

  • UChicago Medicine at Ingalls - Flossmoor

    Flossmoor, Illinois, 60422

    Recruiting

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

    Fort Myers, Florida, 33913

    Recruiting

  • Florida Cancer Specialists & Research Institute, LLC

    Fort Myers, Florida, 33916

    Recruiting

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46804

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Recruiting

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

    Fullerton, California, 92835

    Recruiting

  • Northwest Medical Specialities. PLLC

    Gig Harbor, Washington, 98332

    Not yet recruiting

  • UChicago Medicine Ingalls Memorial

    Harvey, Illinois, 60426

    Recruiting

  • Memorial Cancer Institute

    Hollywood, Florida, 33021

    Recruiting

  • Memorial Healthcare System

    Hollywood, Florida, 33021

    Recruiting

  • Oncology Consultants, PA

    Houston, Texas, 77024

    Recruiting

  • Oncology Consultants, PA.

    Houston, Texas, 77030

    Recruiting

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Community Health Network, Inc

    Indianapolis, Indiana, 46219

    Recruiting

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46227

    Recruiting

  • Community Health Network Investigational Drug Services

    Indianapolis, Indiana, 46250

    Recruiting

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250

    Recruiting

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas, 75063

    Recruiting

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

    Recruiting

  • The University of Kansas Medical Center Medical Office Building

    Kansas City, Kansas, 66160

    Recruiting

  • University of Kansas Hospital Cambridge North Tower A

    Kansas City, Kansas, 66160

    Recruiting

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

    Recruiting

  • Cancer and Blood Research Center, LLC

    Los Alamitos, California, 90720

    Not yet recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Not yet recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Recruiting

  • The Regents of the University of California

    Los Angeles, California, 90095

    Recruiting

  • UCLA Department of Medicine-Hematology/Oncology

    Los Angeles, California, 90095

    Recruiting

  • Allina Health Cancer Institute - Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Recruiting

  • US Oncology Research LLC

    Nashville, Tennessee, 37203

    Recruiting

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

    New Hyde Park, New York, 11042

    Recruiting

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451

    Recruiting

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

    New York, New York, 10028

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Recruiting

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02467

    Recruiting

  • OU Health University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Stephenson Cancer Center (chemo location)

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • American Oncology Network Vista Oncology Division-West office

    Olympia, Washington, 98502

    Recruiting

  • American Oncology Network Vista Oncology Division-East office

    Olympia, Washington, 98506

    Recruiting

  • The University of Chicago Medicine Center for Advanced Care Orland Park

    Orland Park, Illinois, 60462

    Recruiting

  • Florida Cancer Specialists

    Orlando, Florida, 32827

    Recruiting

  • The University of Kansas Cancer Center - Indian Creek Campus

    Overland Park, Kansas, 66211

    Recruiting

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

    Patchogue, New York, 11772

    Recruiting

  • Houston Medical Imaging

    Pearland, Texas, 77581

    Not yet recruiting

  • Memorial Cancer Institute at Memorial Hospital West

    Pembroke Pines, Florida, 33028

    Recruiting

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

    Recruiting

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

    Port Jefferson Station, New York, 11776

    Recruiting

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

    Recruiting

  • Providence Oncology and Hematology Care Clinic - Westside

    Portland, Oregon, 97225

    Recruiting

  • Providence St. Vincent Medical Center- Investigational Drug Services

    Portland, Oregon, 97225

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Recruiting

  • Northwest Medical Specialties, PPLC

    Puyallup, Washington, 98373

    Not yet recruiting

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

    Riverhead, New York, 11901

    Recruiting

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

    Recruiting

  • Allina Health Cancer Institute - United Hospital

    Saint Paul, Minnesota, 55102

    Recruiting

  • Allina Health Cancer Institute

    Saint Paul, Minnesota, 55102

    Recruiting

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

    Active, not recruiting

  • UCLA Department of Medicine - Hematology & Oncology

    Santa Monica, California, 90404

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • Swedish Medical Center

    Seattle, Washington, 98122

    Recruiting

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

    Shirley, New York, 11967

    Recruiting

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104

    Recruiting

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Recruiting

  • Southern Illinois University - Simmons Cancer Institute

    Springfield, Illinois, 62702

    Recruiting

  • Springfield Clinic Radiology - 800 Building

    Springfield, Illinois, 62702

    Recruiting

  • Springfield Clinic Urgent Care Plus

    Springfield, Illinois, 62702

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Recruiting

  • Springfield Clinic Main Campus

    Springfield, Illinois, 62703

    Recruiting

  • Springfield Clinic Radiology - Main Campus

    Springfield, Illinois, 62703

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Recruiting

  • Exigent Research, LLC

    Tacoma, Washington, 98405

    Recruiting

  • Northwest Medical Specialities, PLLC

    Tacoma, Washington, 98405

    Not yet recruiting

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

    The Bronx, New York, 10469

    Recruiting

  • UChicago Medicine at Ingalls - Tinley Park

    Tinley Park, Illinois, 60477

    Recruiting

  • Cancer AND Blood Specialty Clinic

    Torrance, California, 90505

    Not yet recruiting

  • UT Health East Texas HOPE Cancer Center

    Tyler, Texas, 75701

    Recruiting

  • UT Health East Texas Hope Cancer Center

    Tyler, Texas, 75708

    Recruiting

  • Tranquil Clinical Research

    Webster, Texas, 77598

    Not yet recruiting

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Recruiting

Other trials in United States

Spain25 sites, 25 recruiting

  • Hospital HM Nou Delfos

    Barcelona, Catalonia, 08023

    Recruiting

  • Fundación Privada Instituto de Investigación Oncológica de Vall Hebron

    Barcelona, Other, 08035

    Recruiting

  • NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

    Barcelona, OTH, 08023

    Recruiting

  • Farmacia Ensayos clínicos, Unidad START Barcelona

    Barcelona, 08023

    Recruiting

  • Hospital HM Nou Delfos - START Barcelona

    Barcelona, 08023

    Recruiting

  • Hospital Quiron Salud Barcelona

    Barcelona, 08023

    Recruiting

  • Area general-Planta Baixa | Unitat d'investigacio en terapia Molecular del Cancer "la Caixa"

    Barcelona, 08035

    Recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Elche General University Hospital

    Elche, Alicante, 03203

    Recruiting

  • Elche General University Hospital

    Elche, Valencia, 03203

    Recruiting

  • Hospital General Universitario de Elche

    Elche, Valencia, 03203

    Recruiting

  • Elche General University Hospital

    Elche, 03203

    Recruiting

  • Hospital Universitario De Jerez

    Jerez de la Frontera, 10407

    Recruiting

  • UGC Farmacia Ensayos clinicos - Hospital Universitario de Jerez

    Jerez de la Frontera, 10407

    Recruiting

  • Hospital Universitario de Jerez

    Jerez de la Frontera, 11407

    Recruiting

  • Farmacia Ensayos Hospital HM Universitario Sanchinarro

    Madrid, Agrigento, 28050

    Recruiting

  • Fundación de Investigación Hm Hospitales, C.I.F. G-83643841

    Madrid, 28015

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Servicio de Radiologia Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario 12 Octubre

    Madrid, 28041

    Recruiting

  • Hospital HM Sanchinarro, START-Madrid-CIOCC

    Madrid, 28050

    Recruiting

  • Quironsalud Malaga

    Málaga, 129004

    Recruiting

  • Equipo de Farmacia Oncológica- Ensayos Clínicos Servicio de Farmacia Hospital Universitario Marqués

    Santander, Cantabria, 39008

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

Other trials in Spain

United Kingdom9 sites, 9 recruiting

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

    Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Recruiting

  • Sarah Cannon Research Institute

    London, W1G 6AD

    Recruiting

  • Diagnostic centre

    London, W1G 7AF

    Recruiting

  • The Harley Street Clinic

    London, W1G 8BJ

    Recruiting

  • Radiology

    London, W1G 8PP

    Recruiting

  • The Royal Marsden Hospital (Surrey)

    Sutton, Queensland, SM2 5PT

    Recruiting

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

    Recruiting

Other trials in United Kingdom

France6 sites, 5 recruiting

  • Center Hospitalier Universitaire d' Angers

    Angers, 49100

    Active, not recruiting

  • Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne

    Nice, 06189

    Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Recruiting

  • Institut Gustave Roussy Department de Pharmacie Clinique(-1)

    Villejuif, 94805.

    Recruiting

  • lnstitut Gustave Roussy, Departement d'lnnovation Therapeutique et d'Essais Precoces (DITEP)

    Villejuif, 94805.

    Recruiting

Other trials in France

South Korea6 sites, 6 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

    Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • The Catholic University of Korea

    Seoul, 06591

    Recruiting

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

Other trials in South Korea

Switzerland3 sites, 3 recruiting

  • Kantonsspital Graubunden

    Chur, 7000

    Recruiting

  • University Hospital Lausanne CHUV

    Lausanne, 1011

    Recruiting

  • CHUV - Service de pharmacie BH-04, Essais cliniques

    Lausanne, CH-1011

    Recruiting

Other trials in Switzerland

Taiwan3 sites, 3 recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City, R.o.c., 80756

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100, R.O.C

    Recruiting

  • Taipei Veterans General Hospital.

    Taipei, 11217

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors

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.
Being tested
sigvotatug vedotin, pembrolizumab, cisplatin, carboplatin
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus, Ovarian Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sigvotatug vedotinDrug

    Also called SGN-B6A, PF-08046047

    Administered into the vein (IV; intravenously)

  • pembrolizumabDrug

    Also called Keytruda

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

  • cisplatinDrug

    75 mg/m2 every 3 weeks, given by IV

  • carboplatinDrug

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

Study groups in NCT04389632
Study groupRoleWhat they receive
Part A: Dose escalationExperimentalsigvotatug vedotin monotherapy
Receives: Drug: sigvotatug vedotin
Part B: Dose expansionExperimentalsigvotatug vedotin monotherapy
Receives: Drug: sigvotatug vedotin
Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCCExperimentalsigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Receives: Drug: sigvotatug vedotin; Drug: pembrolizumab; Drug: cisplatin; Drug: carboplatin
Part D: sigvotatug vedotin combination therapy in 1L NSCLCExperimentalsigvotatug vedotin + pembrolizumab +/- (carboplatin)
Receives: Drug: sigvotatug vedotin; Drug: pembrolizumab; Drug: carboplatin
Part D: sigvotatug vedotin combination therapy in 1L HNSCCExperimentalsigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Receives: Drug: sigvotatug vedotin; Drug: pembrolizumab; Drug: cisplatin; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

    Measured: 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

  2. Number of patients with laboratory abnormalities

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  3. Number of participants with dose-limiting toxicities (DLTs)

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Secondary outcomes (11)

  1. Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment

    The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to RECIST v1.1.

    Measured: Up to approximately 3 years

  2. Duration of objective response (DOR) per RECIST v1.1 by investigator assessment

    The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause

    Measured: Up to approximately 3 years

  3. Progression-free survival (PFS) per RECIST v1.1 by investigator assessment

    The time from the start of any study treatment to the first documentation of PD, or death due to any cause

    Measured: Up to approximately 3 years

  4. Overall survival (OS)

    The time from the start of any study treatment to the date of death due to any cause

    Measured: Up to approximately 3 years

  5. Area under the concentration-time curve (AUC)

    Pharmacokinetic (PK) endpoint

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  6. Concentration at the end of infusion (Ceoi)

    PK endpoint

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  7. Maximum observed concentration (Cmax)

    PK endpoint

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  8. Time to maximum observed concentration (Tmax)

    PK endpoint

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  9. Trough concentration (Ctrough)

    PK endpoint

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  10. Apparent terminal elimination half-life (t1/2)

    PK endpoint

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

  11. Number of participants with antidrug antibodies (ADAs)

    Measured: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start8 Jun 2020
  3. Primary completion16 Jun 2027 (estimated)
  4. Study completion22 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
1,006 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04389632
Sponsor's protocol ID
SGNB6A-001
Other IDs
C5751001, 2023-508469-34-00, 2023
Status last verified
Jul 2026
First submitted
12 May 2020
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Lyon RP, Jonas M, Frantz C, Trueblood ES, Yumul R, Westendorf L, Hale CJ, Stilwell JL, Yeddula N, Snead KM, Kumar V, Patilea-Vrana GI, Klussman K, Ryan MC. SGN-B6A: A New Vedotin Antibody-Drug Conjugate Directed to Integrin Beta-6 for Multiple Carcinoma Indications. Mol Cancer Ther. 2023 Dec 1;22(12):1444-1453. doi: 10.1158/1535-7163.MCT-22-0817.

    PubMed 37619980

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sigvotatug vedotin, pembrolizumab and cisplatin in people with Carcinoma, Non-Small Cell Lung and Squamous Cell Carcinoma of Head and Neck, run by Seagen, a wholly owned subsidiary of Pfizer at 158 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Spain, United Kingdom, France, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389632, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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