A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors

January 7, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

A Phase 1 Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

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 Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
  • Germany
      • Berlin, Germany, 12200
        • Hamato-Onkologische Phase 1 Unit der Charite/Charite Research Organisation
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28050
        • START Madrid-Hospital Universitario HM Sanchinarro
  • United Kingdom
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
      • Aurora, Colorado, United States, 80045
        • UCHealth Sue Anschutz-Rodgers Eye Center
      • Denver, Colorado, United States, 80218
        • Presbyterian/St Lukes Medical Center
    • Florida
      • Celebration, Florida, United States, 34747
        • AdventHealth Celebration Infusion Center
      • Celebration, Florida, United States, 34747
        • AdventHealth Medical Group Oncology Research at Celebration
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Orlando, Florida, United States, 32827
        • Florida Cancer Specialists
      • Orlando, Florida, United States, 32827
        • Sarah Cannon Research Institute at Florida Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Group
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network, Inc.
      • Indianapolis, Indiana, United States, 46227
        • Community Health Network, Inc.
      • Indianapolis, Indiana, United States, 46256
        • Community Health Network, Inc.
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • START Midwest
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute - Pharmacy
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M.D. Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics, LLC
    • Utah
      • West Valley City, Utah, United States, 84119
        • START Mountain Region

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:

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.
    • 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:

  • 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

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Felmetatug Vedotin (Parts A, B, and C)
Felmetatug Vedotin monotherapy
Drug: Felmetatug Vedotin
Given into the vein (IV; intravenously)
Other Names:
  • SGN-B7H4V
  • PF-08046048
Experimental: Felmetatug Vedotin and Pembrolizumab (Parts D and E)
Felmetatug Vedotin in combination with Pembrolizumab.
Drug: Pembrolizumab
400 mg every 6 weeks, given by IV
Other Names:
  • Keytruda
Drug: Felmetatug Vedotin
Given into the vein (IV; intravenously)
Other Names:
  • SGN-B7H4V
  • PF-08046048

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dose limiting toxicities (DLTs)
Time Frame: Up to 28 days
Up to 28 days
Number of participants with adverse events (AEs)
Time Frame: Through 30 days after last study treatment, up to approximately 5 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 days after last study treatment, up to approximately 5 years
Number of participants with laboratory abnormalities
Time Frame: Through 30-37 days after last study treatment, up to approximately 5 years
Through 30-37 days after last study treatment, up to approximately 5 years
Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level
Time Frame: Through 30-37 days after last study treatment; up to approximately 5 years
Through 30-37 days after last study treatment; up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Maximum concentration (Cmax)
Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Time to maximum concentration (Tmax)
Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Apparent terminal half-life (t1/2)
Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Trough concentration (Ctrough)
Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment, up to approximately 3 years
Incidence of antidrug antibodies (ADAs)
Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years
To be summarized using descriptive statistics.
Through 30-37 days after last study treatment, up to approximately 3 years
Confirmed objective response rate (ORR) by investigator assessment
Time Frame: Up to approximately 5 years
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.
Up to approximately 5 years
Complete response rate (CRR)
Time Frame: Up to approximately 5 years
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
Up to approximately 5 years
Duration of response (DOR)
Time Frame: Up to approximately 5 years
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.
Up to approximately 5 years
Progression-free survival (PFS)
Time Frame: Up to approximately 5 years
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Up to approximately 5 years
Invasive disease-free survival (iDFS)
Time Frame: Up to approximately 5 years
The time from the start of any study treatment until the date of first occurrence of one of the following events: ipsilateral invasive breast tumor (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant (metastatic) recurrence; contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous of basal cell skin cancer); or death from any cause.
Up to approximately 5 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.

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)

January 12, 2022

Primary Completion (Actual)

May 14, 2025

Study Completion (Actual)

May 14, 2025

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNB7H4V-001
  • C5761001 (Other Identifier: Alias Study Number)
  • 2023-503389-22-00 (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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