Ovarian NeoplasmsPhase 1NCT05194072
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
A Phase 1 study testing Felmetatug Vedotin and Pembrolizumab in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 27 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
- What is being tested?
- Felmetatug Vedotin and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 27 sitesin 5 countries
- Study dates
- 12 Jan 2022to 14 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
United States22 sites
UCHealth Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, 80045
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045
AdventHealth Celebration Infusion Center
Celebration, Florida, 34747
AdventHealth Medical Group Oncology Research at Celebration
Celebration, Florida, 34747
Northwestern Medical Group
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Presbyterian/St Lukes Medical Center
Denver, Colorado, 80218
START Midwest
Grand Rapids, Michigan, 49546
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, 77030
Community Health Network, Inc.
Indianapolis, Indiana, 46227
Community Health Network, Inc.
Indianapolis, Indiana, 46250
Community Health Network, Inc.
Indianapolis, Indiana, 46256
Mayo Clinic Florida
Jacksonville, Florida, 32224
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203
Florida Cancer Specialists
Orlando, Florida, 32827
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
START Mountain Region
West Valley City, Utah, 84119
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
START Madrid-Hospital Universitario HM Sanchinarro
Madrid, 28050
Germany1 site
Hamato-Onkologische Phase 1 Unit der Charite/Charite Research Organisation
Berlin, 12200
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms, HER2 Negative Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms
- Being tested
- Felmetatug Vedotin, Pembrolizumab
- Keywords
- High-grade serous epithelial ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, HER2-negative breast cancer, HR positive breast cancer, Triple-negative breast cancer, TNBC, Endometrial carcinoma, Non-small cell lung cancer, NSCLC, SqCC, AC, ACC, Pfizer, Seattle Genetics
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felmetatug VedotinDrug
Also called SGN-B7H4V, PF-08046048
Given into the vein (IV; intravenously)
PembrolizumabDrug
Also called Keytruda
400 mg every 6 weeks, given by IV
| Study group | Role | What they receive |
|---|---|---|
| Felmetatug Vedotin (Parts A, B, and C) | Experimental | Felmetatug Vedotin monotherapy Receives: Drug: Felmetatug Vedotin |
| Felmetatug Vedotin and Pembrolizumab (Parts D and E) | Experimental | Felmetatug Vedotin in combination with Pembrolizumab. Receives: Drug: Felmetatug Vedotin; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 30 days after last study treatment, up to approximately 5 years
Number of participants with laboratory abnormalities
Measured: Through 30-37 days after last study treatment, up to approximately 5 years
Number of participants with dose limiting toxicities (DLTs)
Measured: Up to 28 days
Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level
Measured: Through 30-37 days after last study treatment; up to approximately 5 years
Secondary outcomes (11)
Confirmed objective response rate (ORR) by investigator assessment
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.
Measured: Up to approximately 5 years
Complete response rate (CRR)
The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.
Measured: Up to approximately 5 years
Duration of response (DOR)
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.
Measured: Up to approximately 5 years
Progression-free survival (PFS)
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Measured: Up to approximately 5 years
Invasive disease-free survival (iDFS)
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.
Measured: Up to approximately 5 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics.
Measured: Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics.
Measured: Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics.
Measured: Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics.
Measured: Through 30-37 days after last study treatment, up to approximately 3 years
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics.
Measured: Through 30-37 days after last study treatment, up to approximately 3 years
Incidence of antidrug antibodies (ADAs)
To be summarized using descriptive statistics.
Measured: Through 30-37 days after last study treatment, up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start12 Jan 2022
- Primary completion14 May 2025
- Study completion14 May 2025
Why it stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194072
- Sponsor's protocol ID
- SGNB7H4V-001
- Other IDs
- C5761001, 2023-503389-22-00, 2023
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05194072
- Acronym / sponsor ID
- SGNB7H4V-001
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms, HER2 Negative Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms
- Keywords
- High-grade serous epithelial ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, HER2-negative breast cancer, HR positive breast cancer, Triple-negative breast cancer, TNBC, Endometrial carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Seagen, a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Felmetatug Vedotin (Parts A, B, and C) | Experimental | Drug: Felmetatug VedotinFelmetatug Vedotin monotherapy |
| Felmetatug Vedotin and Pembrolizumab (Parts D and E) | Experimental | Drug: Felmetatug Vedotin, Drug: PembrolizumabFelmetatug Vedotin in combination with Pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:
- 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
Key exclusion criteria (9 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Felmetatug VedotinAlso: SGN-B7H4V, PF-08046048Given into the vein (IV; intravenously) | Drug | Felmetatug Vedotin (Parts A, B, and C), Felmetatug Vedotin and Pembrolizumab (Parts D and E) |
| PembrolizumabAlso: Keytruda400 mg every 6 weeks, given by IV | Drug | Felmetatug Vedotin and Pembrolizumab (Parts D and E) |
Primary outcome
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.
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days after last study treatment, up to approximately 5 years
Number of participants with dose limiting toxicities (DLTs)
Time frame: Up to 28 days
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
11 secondary outcomes
Confirmed objective response rate (ORR) by investigator assessment
Time frame: Up to approximately 5 years
Complete response rate (CRR)
Time frame: Up to approximately 5 years
Duration of response (DOR)
Time frame: Up to approximately 5 years
Progression-free survival (PFS)
Time frame: Up to approximately 5 years
Invasive disease-free survival (iDFS)
Time frame: Up to approximately 5 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Time frame: 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
PK parameter - Time to maximum concentration (Tmax)
Time frame: 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
PK parameter - Trough concentration (Ctrough)
Time frame: 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
Results and safety
The study was stopped early (reason given: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Felmetatug Vedotin and Pembrolizumab in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 27 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain, Canada, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Through 30 days after last study treatment, up to approximately 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.