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Taking people in United StatesPhase 1

Tests sigvotatug vedotin, alone or combined, in advanced solid tumors

Tests sigvotatug vedotin, with or without other drugs, in adults with advanced solid tumors.

Key facts

Who runs it
Seagen, a wholly owned subsidiary of Pfizer
Where
Anaheim, Anchorage, Babylon, Bonney Lake, Boston, Brooklyn, Calumet City, Chicago, Cleveland, Coon Rapids, Crown Point, Edmonds, Fairfax, Fairway, Fayetteville, Federal Way, Flossmoor, Fort Myers, Fort Wayne, Fullerton, Gig Harbor, Harvey, Hollywood, Houston, Indianapolis, Irving, Kansas City, Las Vegas, Los Alamitos, Los Angeles, Minneapolis, Nashville, New Hyde Park, New Lenox, New York, Newton, Oklahoma City, Olympia, Orland Park, Orlando, Overland Park, Patchogue, Pearland, Pembroke Pines, Port Jefferson Station, Portland, Puyallup, Riverhead, Rogers, Saint Paul, San Antonio, Santa Monica, Seattle, Shirley, Sioux Falls, Springdale, Springfield, Tacoma, The Bronx, Tinley Park, Torrance, Tyler, Webster, and Westwood, United StatesSee the 101 sitesAlso in 6 other countries, 36 sites
Registry title
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
1,006 people, planned
Started
8 Jun 2020
Expected to end
22 Mar 2029
Type of study
Interventional, 5 groups
Treatments tested
  • sigvotatug vedotin
  • pembrolizumab
  • cisplatin
  • carboplatin
Record updated
6 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors, such as lung, head and neck, breast, esophageal, bladder or ovarian cancer, to test the drug sigvotatug vedotin alone or with other drugs.

Age
18 years or older
Sex
All sexes can join
Disease stage
Metastatic or unresectable solid cancer of a listed type, with measurable disease and ECOG Performance Status 0 or 1. Parts A and B: disease that came back, did not respond, or could not be treated with standard therapy. Parts C and D: no earlier systemic treatment for advanced disease.
Earlier treatment
Part A: no appropriate standard treatment left. Part B: platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available. Parts C and D: no earlier systemic treatment for locally advanced or metastatic disease. Earlier treatment with an MMAE-containing drug or a drug targeting integrin beta-6 is not allowed.

Main reasons for not taking part

  • Another cancer within the last 3 years (some exceptions)
  • Active brain metastases or carcinomatous meningitis (some treated, stable cases can join)
  • Earlier treatment with an MMAE-containing drug or an integrin beta-6 drug
  • Nerve damage (neuropathy) of Grade 1 or 2 or worse, depending on the study group
  • History of interstitial lung disease or pneumonitis that needed steroids, or serious lung disease

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6
  • 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
  • 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 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
  • 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
  • Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses
  • 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
  • Carcinomatous meningitis
  • 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

Where in United States

Also in 6 other countries, 36 sites

  • Providence Medical FoundationAnaheim, United StatesTaking people
  • Alaska Oncology and HematologyAnchorage, United StatesTaking people
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsBabylon, United StatesTaking people
  • Northwest Medical Specialities. PLLCBonney Lake, United StatesNot yet recruiting
  • Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
  • Beth Israel Deaconess Medical Center,East Campus Research PharmacyBoston, United StatesTaking people
  • Brigham & Women's HospitalBoston, United StatesTaking people
  • Dana-Farber Cancer InstituteBoston, United StatesTaking people
  • Massachusetts General HospitalBoston, United StatesTaking people
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsBrooklyn, United StatesTaking people
  • Ingalls Family Care CenterCalumet City, United StatesTaking people
  • The University Of ChicagoChicago, United StatesTaking people
  • UChicago Medicine - River EastChicago, United StatesTaking people
  • University of Chicago Medical CenterChicago, United StatesTaking people
  • University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
  • Allina Health Cancer Institute - Mercy HospitalCoon Rapids, United StatesTaking people
  • UChicago Medicine Northwest IndianaCrown Point, United StatesTaking people
  • Swedish Cancer Institute - Edmonds CampusEdmonds, United StatesTaking people
  • Virginia Cancer SpecialistsFairfax, United StatesTaking people
  • The University of Kansas - Clinical Research CenterFairway, United StatesTaking people
  • The University of Kansas Cancer Center, Investigational Drug ServicesFairway, United StatesTaking people
  • Highlands Oncology GroupFayetteville, United StatesTaking people
  • Northwest Medical Specialities.PLLCFederal Way, United StatesNot yet recruiting
  • UChicago Medicine at Ingalls - FlossmoorFlossmoor, United StatesTaking people
  • American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista OncologyFort Myers, United StatesTaking people
  • Florida Cancer Specialists & Research Institute, LLCFort Myers, United StatesTaking people
  • Fort Wayne Medical Oncology and Hematology, IncFort Wayne, United StatesTaking people
  • Providence Medical FoundationFullerton, United StatesTaking people
  • Providence St. Jude Medical Center Virginia K Crosson and Infusion CenterFullerton, United StatesTaking people
  • Northwest Medical Specialities. PLLCGig Harbor, United StatesNot yet recruiting
  • UChicago Medicine Ingalls MemorialHarvey, United StatesTaking people
  • Memorial Cancer InstituteHollywood, United StatesTaking people
  • Memorial Healthcare SystemHollywood, United StatesTaking people
  • Oncology Consultants, PAHouston, United StatesTaking people
  • The University of Texas M. D. Anderson Cancer CenterHouston, United StatesTaking people
  • Community Health Network Investigational Drug ServicesIndianapolis, United StatesTaking people
  • Community Health Network, IncIndianapolis, United StatesTaking people
  • US Oncology Investigational Product Center (IPC)Irving, United StatesTaking people
  • The University of Kansas HospitalKansas City, United StatesTaking people
  • The University of Kansas Medical Center Medical Office BuildingKansas City, United StatesTaking people
  • University of Kansas Hospital Cambridge North Tower AKansas City, United StatesTaking people
  • University of Kansas Medical Center Research InstituteKansas City, United StatesTaking people
  • Comprehensive Cancer Centers of NevadaLas Vegas, United StatesTaking people
  • Cancer and Blood Research Center, LLCLos Alamitos, United StatesNot yet recruiting
  • Cancer and Blood Specialty ClinicLos Alamitos, United StatesNot yet recruiting
  • Ronald Reagan UCLA Medical CenterLos Angeles, United StatesTaking people
  • The Regents of the University of CaliforniaLos Angeles, United StatesTaking people
  • UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesTaking people
  • Allina Health Cancer Institute - Abbott Northwestern HospitalMinneapolis, United StatesTaking people
  • US Oncology Research LLCNashville, United StatesTaking people
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsNew Hyde Park, United StatesTaking people
  • University of Chicago Comprehensive Cancer Center at Silver Cross HospitalNew Lenox, United StatesTaking people
  • Columbia University Irving Medical CenterNew York, United StatesTaking people
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsNew York, United StatesTaking people
  • Dana-Farber Cancer Institute - Chestnut HillNewton, United StatesTaking people
  • OU Health University of Oklahoma Medical CenterOklahoma City, United StatesTaking people
  • Stephenson Cancer Center (chemo location)Oklahoma City, United StatesTaking people
  • University of Oklahoma Health Science CenterOklahoma City, United StatesTaking people
  • American Oncology Network Vista Oncology Division-East officeOlympia, United StatesTaking people
  • American Oncology Network Vista Oncology Division-West officeOlympia, United StatesTaking people
  • The University of Chicago Medicine Center for Advanced Care Orland ParkOrland Park, United StatesTaking people
  • Florida Cancer SpecialistsOrlando, United StatesTaking people
  • The University of Kansas Cancer Center - Indian Creek CampusOverland Park, United StatesTaking people
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsPatchogue, United StatesTaking people
  • Houston Medical ImagingPearland, United StatesNot yet recruiting
  • Memorial Cancer Institute at Memorial Hospital WestPembroke Pines, United StatesTaking people
  • Memorial Hospital WestPembroke Pines, United StatesTaking people
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsPort Jefferson Station, United StatesTaking people
  • Providence Cancer Institute Franz ClinicPortland, United StatesTaking people
  • Providence Oncology and Hematology Care Clinic - WestsidePortland, United StatesTaking people
  • Providence St. Vincent Medical CenterPortland, United StatesTaking people
  • Providence St. Vincent Medical Center- Investigational Drug ServicesPortland, United StatesTaking people
  • Northwest Medical Specialties, PPLCPuyallup, United StatesNot yet recruiting
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsRiverhead, United StatesTaking people
  • Highlands Oncology GroupRogers, United StatesTaking people
  • Allina Health Cancer InstituteSaint Paul, United StatesTaking people
  • Allina Health Cancer Institute - United HospitalSaint Paul, United StatesTaking people
  • South Texas Accelerated Research Therapeutics, LLCSan Antonio, United StatesNo longer taking part
  • UCLA Department of Medicine - Hematology & OncologySanta Monica, United StatesTaking people
  • Swedish Cancer InstituteSeattle, United StatesTaking people
  • Swedish Medical CenterSeattle, United StatesTaking people
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsShirley, United StatesTaking people
  • Sanford Cancer CenterSioux Falls, United StatesTaking people
  • Sanford USD Medical CenterSioux Falls, United StatesTaking people
  • Highlands Oncology GroupSpringdale, United StatesTaking people
  • Southern Illinois University - Simmons Cancer InstituteSpringfield, United StatesTaking people
  • Springfield ClinicSpringfield, United StatesTaking people
  • Springfield Clinic Main CampusSpringfield, United StatesTaking people
  • Springfield Clinic Radiology - 800 BuildingSpringfield, United StatesTaking people
  • Springfield Clinic Radiology - Main CampusSpringfield, United StatesTaking people
  • Springfield Clinic Urgent Care PlusSpringfield, United StatesTaking people
  • Springfield Memorial HospitalSpringfield, United StatesTaking people
  • Exigent Research, LLCTacoma, United StatesTaking people
  • Northwest Medical Specialities, PLLCTacoma, United StatesNot yet recruiting
  • North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood SpecialistsThe Bronx, United StatesTaking people
  • UChicago Medicine at Ingalls - Tinley ParkTinley Park, United StatesTaking people
  • Cancer AND Blood Specialty ClinicTorrance, United StatesNot yet recruiting
  • UT Health East Texas HOPE Cancer CenterTyler, United StatesTaking people
  • Tranquil Clinical ResearchWebster, United StatesNot yet recruiting
  • The University of Kansas Cancer Center - WestwoodWestwood, United StatesTaking people
  • University of Kansas Cancer CenterWestwood, United StatesTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 5 groups in the trial

  • Part A: Dose escalationTreatment being tested

    sigvotatug vedotin monotherapy

    Treatment: sigvotatug vedotin

  • Part B: Dose expansionTreatment being tested

    sigvotatug vedotin monotherapy

    Treatment: sigvotatug vedotin

  • Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCCTreatment being tested

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

    Treatment: sigvotatug vedotin, pembrolizumab, cisplatin, and carboplatin

  • Part D: sigvotatug vedotin combination therapy in 1L NSCLCTreatment being tested

    sigvotatug vedotin + pembrolizumab +/- (carboplatin)

    Treatment: sigvotatug vedotin, pembrolizumab, and carboplatin

  • Part D: sigvotatug vedotin combination therapy in 1L HNSCCTreatment being tested

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

    Treatment: sigvotatug vedotin, pembrolizumab, cisplatin, and carboplatin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors
Plain-language title
Tests sigvotatug vedotin, alone or combined, in advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
6 July 2026