Study Stopped
The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
A Phase 1 Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
3 other identifiers
interventional
250
5 countries
27
Brief Summary
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Typical duration for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2022
CompletedStudy Start
First participant enrolled
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2025
CompletedJanuary 9, 2026
January 1, 2026
3.3 years
January 3, 2022
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
Through 30 days after last study treatment, up to approximately 5 years
Number of participants with laboratory abnormalities
Through 30-37 days after last study treatment, up to approximately 5 years
Number of participants with dose limiting toxicities (DLTs)
Up to 28 days
Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level
Through 30-37 days after last study treatment; up to approximately 5 years
Secondary Outcomes (11)
Confirmed objective response rate (ORR) by investigator assessment
Up to approximately 5 years
Complete response rate (CRR)
Up to approximately 5 years
Duration of response (DOR)
Up to approximately 5 years
Progression-free survival (PFS)
Up to approximately 5 years
Invasive disease-free survival (iDFS)
Up to approximately 5 years
- +6 more secondary outcomes
Study Arms (2)
Felmetatug Vedotin (Parts A, B, and C)
EXPERIMENTALFelmetatug Vedotin monotherapy
Felmetatug Vedotin and Pembrolizumab (Parts D and E)
EXPERIMENTALFelmetatug Vedotin in combination with Pembrolizumab.
Interventions
Given into the vein (IV; intravenously)
400 mg every 6 weeks, given by IV
Eligibility Criteria
You may qualify if:
- For Parts A, B, and C:
- 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.
- +5 more criteria
You may not qualify if:
- History of another malignancy within 3 years before the first dose of study drug. 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
UCHealth Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045, United States
Presbyterian/St Lukes Medical Center
Denver, Colorado, 80218, United States
AdventHealth Celebration Infusion Center
Celebration, Florida, 34747, United States
AdventHealth Medical Group Oncology Research at Celebration
Celebration, Florida, 34747, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Florida Cancer Specialists
Orlando, Florida, 32827, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46227, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46250, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46256, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, 77030, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229, United States
START Mountain Region
West Valley City, Utah, 84119, United States
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Hamato-Onkologische Phase 1 Unit der Charite/Charite Research Organisation
Berlin, 12200, Germany
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
START Madrid-Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2022
First Posted
January 18, 2022
Study Start
January 12, 2022
Primary Completion
May 14, 2025
Study Completion
May 14, 2025
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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.