A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
NCT ID: NCT05194072
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
250 participants
INTERVENTIONAL
2022-01-12
2025-05-14
Brief Summary
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This study is seeking for participants who either have cancer:
* that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable),
* has spread through the body (metastatic), or have some cancer left over after surgery.
This study will have five parts.
* Parts A and B of the study will find out how much Felmetatug Vedotin should be given to participants.
* Part C will use the amount found in Parts A and B to find out how safe Felmetatug Vedotin is and if it works to treat solid tumor cancers.
* Part D will find out if and how much Felmetatug Vedotin can be given with pembrolizumab.
* Part E will use the amount found in Part D to find out how safe Felmetatug Vedotin with pembrolizumab is and if it works to treat triple negative breast cancer.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Felmetatug Vedotin (Parts A, B, and C)
Felmetatug Vedotin monotherapy
Felmetatug Vedotin
Given into the vein (IV; intravenously)
Felmetatug Vedotin and Pembrolizumab (Parts D and E)
Felmetatug Vedotin in combination with Pembrolizumab.
Felmetatug Vedotin
Given into the vein (IV; intravenously)
Pembrolizumab
400 mg every 6 weeks, given by IV
Interventions
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Felmetatug Vedotin
Given into the vein (IV; intravenously)
Pembrolizumab
400 mg every 6 weeks, given by IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:
* High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
* HER2-negative, HR positive breast cancer
* Triple-negative breast cancer (TNBC)
* Endometrial carcinoma
* Non-small cell lung cancer (Squamous cell carcinoma \[SqCC\], Adenocarcinoma \[AC\])
* Cholangiocarcinoma or gallbladder carcinoma
* Adenoid cystic carcinoma (ACC) For Part D: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC.
For Part E:
* Cohort E1: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS≥10 by local testing
* Cohort E2: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS\<10 by local testing
* Cohort E3: Participants must have triple negative breast cancer with residual disease following neoadjuvant therapy and definitive surgery
* Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option
* Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies.
* Part D and E1/E2: Participants must have had no prior treatment for locally advanced unresectable or metastatic TNBC
* Part E3: Participants must have completed at least 6 cycles of neoadjuvant therapy for locally advanced unresectable or metastatic TNBC
* Tumor tissue is required for enrollment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Measurable disease per RECIST version 1.1 at baseline (not applicable for E3 participants).
Exclusion Criteria
* 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 corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.
* Carcinomatous meningitis
* Previous receipt of an MMAE-containing agent or an agent targeting B7-H4
* Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
* Corneal disease or injury requiring treatment or active monitoring
18 Years
ALL
No
Sponsors
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Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UCHealth Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States
Presbyterian/St Lukes Medical Center
Denver, Colorado, United States
AdventHealth Celebration Infusion Center
Celebration, Florida, United States
AdventHealth Medical Group Oncology Research at Celebration
Celebration, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Florida Cancer Specialists
Orlando, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
Northwestern Medical Group
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
START Midwest
Grand Rapids, Michigan, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Hamato-Onkologische Phase 1 Unit der Charite/Charite Research Organisation
Berlin, , Germany
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
START Madrid-Hospital Universitario HM Sanchinarro
Madrid, , Spain
Sarah Cannon Research Institute
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5761001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503389-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
SGNB7H4V-001
Identifier Type: -
Identifier Source: org_study_id
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