A Study of Sigvotatug Vedotin in Advanced Solid Tumors

May 8, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1006

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49100
        • Active, not recruiting
        • Center Hospitalier Universitaire d' Angers
      • Nice, France, 06189
        • Recruiting
        • Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
      • Poitiers, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Institut de Cancérologie de Lorraine
      • Villejuif, France, 94805.
        • Recruiting
        • lnstitut Gustave Roussy, Departement d'lnnovation Therapeutique et d'Essais Precoces (DITEP)
      • Villejuif, France, 94805.
        • Recruiting
        • Institut Gustave Roussy Department de Pharmacie Clinique(-1)
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea
      • Seoul, South Korea, 07061
        • Recruiting
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Recruiting
        • Chungbuk National University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08023
        • Recruiting
        • Hospital Quiron Salud Barcelona
      • Barcelona, Spain, 08023
        • Recruiting
        • Farmacia Ensayos clínicos, Unidad START Barcelona
      • Barcelona, Spain, 08023
        • Recruiting
        • Hospital HM Nou Delfos - START Barcelona
      • Barcelona, Spain, 08035
        • Recruiting
        • Area general-Planta Baixa | Unitat d'investigacio en terapia Molecular del Cancer "la Caixa"
      • Barcelona, Spain, 08023
        • Recruiting
        • NEXT Oncology - IOB Hospital Quironsalud Barcelona
      • Elche, Spain, 03203
        • Recruiting
        • Elche General University Hospital
      • Jerez de la Frontera, Spain, 10407
        • Recruiting
        • Hospital Universitario de Jerez
      • Jerez de la Frontera, Spain, 10407
        • Recruiting
        • UGC Farmacia Ensayos clinicos - Hospital Universitario de Jerez
      • Jerez de la Frontera, Spain, 11407
        • Recruiting
        • Hospital Universitario de Jerez
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 Octubre
      • Madrid, Spain, 28034
        • Recruiting
        • Servicio de Radiologia Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital HM Sanchinarro, START-Madrid-CIOCC
      • Madrid, Spain, 28015
        • Recruiting
        • Fundación de Investigación Hm Hospitales, C.I.F. G-83643841
      • Málaga, Spain, 129004
        • Recruiting
        • Quironsalud Malaga
    • Agrigento
      • Madrid, Agrigento, Spain, 28050
        • Recruiting
        • Farmacia Ensayos Hospital HM Universitario Sanchinarro
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Elche General University Hospital
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Equipo de Farmacia Oncológica- Ensayos Clínicos Servicio de Farmacia Hospital Universitario Marqués
    • Catalonia
      • Barcelona, Catalonia, Spain, 08023
        • Recruiting
        • Hospital HM Nou Delfos
    • OTH
      • Barcelona, OTH, Spain, 08023
        • Recruiting
        • NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
    • Other
      • Barcelona, Other, Spain, 08035
        • Recruiting
        • Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
    • Valencia
      • Elche, Valencia, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
      • Elche, Valencia, Spain, 03203
        • Recruiting
        • Elche General University Hospital
  • Switzerland
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden
      • Lausanne, Switzerland, 1011
        • Recruiting
        • University Hospital Lausanne CHUV
        • Principal Investigator:
          • Solange Peters
      • Lausanne, Switzerland, CH-1011
        • Recruiting
        • CHUV - Service de pharmacie BH-04, Essais cliniques
  • Taiwan
      • Taipei, Taiwan, 100, R.O.C
        • Not yet recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital.
    • R.o.c.
      • Kaohsiung City, R.o.c., Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, W1G 8BJ
        • Recruiting
        • The Harley Street Clinic
      • London, United Kingdom, W1G 8PP
        • Recruiting
        • Radiology
      • London, United Kingdom, W1G 7AF
        • Recruiting
        • Diagnostic Centre
    • Queensland
      • Sutton, Queensland, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden Hospital (Surrey)
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Oncology and Hematology
        • Contact:
        • Principal Investigator:
          • Steven Liu, MD
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group
        • Principal Investigator:
          • J. Thaddeus Beck
        • Contact:
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Providence Medical Foundation
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Yung Lyou
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence St. Jude Medical Center Virginia K Crosson and Infusion Center
      • Los Alamitos, California, United States, 90720
        • Not yet recruiting
        • Cancer and Blood Specialty Clinic
      • Los Alamitos, California, United States, 90720
        • Not yet recruiting
        • Cancer and Blood Research Center, LLC
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Department of Medicine-Hematology/Oncology
      • Los Angeles, California, United States, 90095
        • Recruiting
        • The Regents of the University of California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA Department of Medicine - Hematology & Oncology
      • Torrance, California, United States, 90505
        • Not yet recruiting
        • Cancer and Blood Specialty Clinic
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Recruiting
        • Florida Cancer Specialists & Research Institute, LLC
      • Fort Myers, Florida, United States, 33913
        • Recruiting
        • American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Healthcare System
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Cancer Institute
        • Principal Investigator:
          • Luis Raez
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Florida Cancer Specialists
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Hospital West
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Cancer Institute at Memorial Hospital West
    • Illinois
      • Calumet City, Illinois, United States, 60409
        • Recruiting
        • Ingalls Family Care Center
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • UChicago Medicine - River East
      • Flossmoor, Illinois, United States, 60422
        • Recruiting
        • UChicago Medicine at Ingalls - Flossmoor
      • Harvey, Illinois, United States, 60426
        • Recruiting
        • UChicago Medicine Ingalls Memorial
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • The University of Chicago Medicine Center for Advanced Care Orland Park
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic Radiology - 800 Building
      • Springfield, Illinois, United States, 62703
        • Recruiting
        • Springfield Clinic Radiology - Main Campus
      • Springfield, Illinois, United States, 62703
        • Recruiting
        • Springfield Clinic Main Campus
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University - Simmons Cancer Institute
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic Urgent Care Plus
      • Tinley Park, Illinois, United States, 60477
        • Recruiting
        • UChicago Medicine at Ingalls - Tinley Park
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • UChicago Medicine - Northwest Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Medical Oncology and Hematology, Inc
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network, Inc.
      • Indianapolis, Indiana, United States, 46227
        • Recruiting
        • Community Health Network, Inc.
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network Investigational Drug Services
      • Indianapolis, Indiana, United States, 46219
        • Recruiting
        • Community Health Network, Inc
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Clinical Research Center
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center, Investigational Drug Services
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center Research Institute
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Hospital
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Medical Center Medical Office Building
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Hospital Cambridge North Tower A
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • The University of Kansas Cancer Center - Indian Creek Campus
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Chao H Huang
        • Contact:
          • University of Kansas Cancer Center Nurse Inbox
          • Phone Number: 913-945-7552
          • Email: CTNurseNav@kumc.edu
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center - Westwood
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Bruno Bockorny, MD
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Kartik Sehgal
        • Contact:
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center,East Campus Research Pharmacy
      • Newton, Massachusetts, United States, 02467
        • Recruiting
        • Dana-Farber Cancer Institute - Chestnut Hill
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Allina Health Cancer Institute - Mercy Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Health Cancer Institute - Abbott Northwestern Hospital
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • Allina Health Cancer Institute
        • Principal Investigator:
          • Charlene Fares
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
        • Principal Investigator:
          • Edwin C Kingsley
    • New York
      • Babylon, New York, United States, 11702
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • Brooklyn, New York, United States, 11210
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10028
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • Patchogue, New York, United States, 11772
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • Port Jefferson Station, New York, United States, 11776
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • Riverhead, New York, United States, 11901
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • Shirley, New York, United States, 11967
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
      • The Bronx, New York, United States, 10469
        • Recruiting
        • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Active, not recruiting
        • University Hospitals Cleveland Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Science Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health University of Oklahoma Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Cancer Center (chemo location)
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute Franz Clinic
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Oncology and Hematology Care Clinic - Westside
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center- Investigational Drug Services
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford USD Medical Center
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center
        • Contact:
        • Principal Investigator:
          • Steven Powell
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • US Oncology Research LLC
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
      • Houston, Texas, United States, 77024
        • Recruiting
        • Oncology Consultants, PA
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants, PA.
      • Irving, Texas, United States, 75063
        • Recruiting
        • US Oncology Investigational Product Center (IPC)
      • Pearland, Texas, United States, 77581
        • Not yet recruiting
        • Houston Medical Imaging
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • South Texas Accelerated Research Therapeutics, LLC
      • Tyler, Texas, United States, 75701
        • Recruiting
        • UT health east Texas HOPE Cancer Center
        • Principal Investigator:
          • Robert Droder
        • Contact:
      • Tyler, Texas, United States, 75708
        • Recruiting
        • UT health east Texas HOPE Cancer Center
      • Webster, Texas, United States, 77598
        • Not yet recruiting
        • Tranquil Clinical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
    • Washington
      • Bonney Lake, Washington, United States, 98391
        • Not yet recruiting
        • Northwest Medical Specialities. PLLC
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute Edmonds Campus
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute - Edmonds Campus
      • Federal Way, Washington, United States, 98003
        • Not yet recruiting
        • Northwest Medical Specialities.PLLC
      • Gig Harbor, Washington, United States, 98332
        • Not yet recruiting
        • Northwest Medical Specialities. PLLC
      • Olympia, Washington, United States, 98502
        • Recruiting
        • American Oncology Network Vista Oncology Division-West office
      • Olympia, Washington, United States, 98506
        • Recruiting
        • American Oncology Network Vista Oncology Division-East office
      • Puyallup, Washington, United States, 98373
        • Not yet recruiting
        • Northwest Medical Specialties, PPLC
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
      • Tacoma, Washington, United States, 98405
        • Not yet recruiting
        • Northwest Medical Specialities, PLLC
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Exigent Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Dose escalation
sigvotatug vedotin monotherapy
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
  • PF-08046047
Experimental: Part B: Dose expansion
sigvotatug vedotin monotherapy
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
  • PF-08046047
Experimental: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Drug: pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Names:
  • Keytruda
Drug: cisplatin
75 mg/m2 every 3 weeks, given by IV
Drug: carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
  • PF-08046047
Experimental: Part D: sigvotatug vedotin combination therapy in 1L NSCLC
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
Drug: pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Names:
  • Keytruda
Drug: carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
  • PF-08046047
Experimental: Part D: sigvotatug vedotin combination therapy in 1L HNSCC
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Drug: pembrolizumab
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Other Names:
  • Keytruda
Drug: cisplatin
75 mg/m2 every 3 weeks, given by IV
Drug: carboplatin
AUC 5 mg/mL per min every 3 weeks, given by IV
Drug: sigvotatug vedotin
Administered into the vein (IV; intravenously)
Other Names:
  • SGN-B6A
  • PF-08046047

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 3 years
The time from the start of any study treatment to the date of death due to any cause
Up to approximately 3 years
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to RECIST v1.1.
Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
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
Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The time from the start of any study treatment to the first documentation of PD, or death due to any cause
Up to approximately 3 years
Area under the concentration-time curve (AUC)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Pharmacokinetic (PK) endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Concentration at the end of infusion (Ceoi)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Maximum observed concentration (Cmax)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Time to maximum observed concentration (Tmax)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Trough concentration (Ctrough)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Apparent terminal elimination half-life (t1/2)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
PK endpoint
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with antidrug antibodies (ADAs)
Time Frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2020

Primary Completion (Estimated)

June 16, 2027

Study Completion (Estimated)

March 22, 2029

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNB6A-001
  • C5751001 (Other Identifier: Alias Study Number)
  • 2023-508469-34-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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