> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-felmetatug-vedotin-sgn-b7h4v-in-advanced-solid-b18fd694-d575-41e6-925e-9ce02c62b3b1 > Record changed: 2026-10-13 # A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors NCT05194072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) Lead sponsor Seagen, a wholly owned subsidiary of Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) Start date 2022-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) Number of sites 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Short title** A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Official title** A Phase 1 Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Reason stopped** The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Dates **Completion date** 2025-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **First posted** 2022-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Registry last updated** 2026-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Primary completion date** 2025-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Start date** 2022-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Size and sites **Actual participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Protocol amendments** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Number of sites** 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Lead sponsor** Seagen, a wholly owned subsidiary of Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Identifiers **Registry ID** NCT05194072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **ClinicalTrials.gov ID** NCT05194072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Outcomes ### Primary outcomes 1. Number of participants with adverse events (AEs) Timeframe: 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. 2. Number of participants with laboratory abnormalities Timeframe: Through 30-37 days after last study treatment, up to approximately 5 years 3. Number of participants with dose limiting toxicities (DLTs) Timeframe: Up to 28 days 4. Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level Timeframe: Through 30-37 days after last study treatment; up to approximately 5 years ### Secondary outcomes 1. Confirmed objective response rate (ORR) by investigator assessment Timeframe: 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. 2. Complete response rate (CRR) Timeframe: Up to approximately 5 years The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1. 3. Duration of response (DOR) Timeframe: 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. 4. Progression-free survival (PFS) Timeframe: 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. 5. Invasive disease-free survival (iDFS) Timeframe: 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. 6. Pharmacokinetic (PK) parameter - Area under the curve (AUC) Timeframe: Through 30-37 days after last study treatment; up to approximately 3 years To be summarized using descriptive statistics. 7. PK parameter - Maximum concentration (Cmax) Timeframe: Through 30-37 days after last study treatment, up to approximately 3 years To be summarized using descriptive statistics. 8. PK parameter - Time to maximum concentration (Tmax) Timeframe: Through 30-37 days after last study treatment, up to approximately 3 years To be summarized using descriptive statistics. 9. PK parameter - Apparent terminal half-life (t1/2) Timeframe: Through 30-37 days after last study treatment, up to approximately 3 years To be summarized using descriptive statistics. 10. PK parameter - Trough concentration (Ctrough) Timeframe: Through 30-37 days after last study treatment, up to approximately 3 years To be summarized using descriptive statistics. 11. Incidence of antidrug antibodies (ADAs) Timeframe: Through 30-37 days after last study treatment, up to approximately 3 years To be summarized using descriptive statistics. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Sites - UCHealth Sue Anschutz-Rodgers Eye CenterAurora, United States - University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Aurora, United States - University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Aurora, United States - University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)Aurora, United States - Presbyterian/St Lukes Medical CenterDenver, United States - AdventHealth Celebration Infusion CenterCelebration, United States - AdventHealth Medical Group Oncology Research at CelebrationCelebration, United States - Mayo Clinic FloridaJacksonville, United States - Florida Cancer SpecialistsOrlando, United States - Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, United States - Northwestern Medical GroupChicago, United States - Northwestern Memorial HospitalChicago, United States - Community Health Network, Inc.Indianapolis, United States - Community Health Network, Inc.Indianapolis, United States - Community Health Network, Inc.Indianapolis, United States - START MidwestGrand Rapids, United States - Sarah Cannon Research Institute - PharmacyNashville, United States - SCRI Oncology PartnersNashville, United States - The University of Texas M.D. Anderson Cancer CenterHouston, United States - The University of Texas MD Anderson Cancer Center Investigational Pharmacy ServicesHouston, United States - South Texas Accelerated Research Therapeutics, LLCSan Antonio, United States - START Mountain RegionWest Valley City, United States - The Ottawa Hospital Cancer CentreOttawa, Canada - Hamato-Onkologische Phase 1 Unit der Charite/Charite Research OrganisationBerlin, Germany - Hospital Universitari Vall d'HebronBarcelona, Spain And 2 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=SGNB7H4V-001) ### Other registry identifiers (3) - 2023 - 2023-503389-22-00 - C5761001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05194072) ## Related records ### Drugs (2) - [Felmetatug vedotin](https://trialight.com/data/asset/felmetatug-vedotin-c3621845-565c-4e9e-af46-cad50113b4cc.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Seagen, a wholly owned subsidiary of Pfizer](https://trialight.com/data/company/seagen-a-wholly-owned-subsidiary-of-pfizer-cfa70ada-470e-4311-a9a8-67d61cc8f6be.md) ### Conditions (11) - [Adenoid cystic carcinoma](https://trialight.com/data/condition/adenoid-cystic-carcinoma-6c5702ee-925e-504d-8b2d-477a0008f140.md) - [Cholangiocarcinoma](https://trialight.com/data/condition/cholangiocarcinoma-3777afe4-5189-5eb1-82f8-0c3446cb902f.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Gallbladder carcinoma](https://trialight.com/data/condition/gallbladder-carcinoma-0f30c5c6-4ee3-58f9-a97d-6499bb1158fb.md) - [Gallbladder neoplasm](https://trialight.com/data/condition/gallbladder-neoplasm-319460a9-bcad-5f90-b7cd-898434918a95.md) - [Hormone receptor-positive breast cancer](https://trialight.com/data/condition/hormone-receptor-positive-breast-cancer-1615b277-fa91-513c-addf-371a0c1fe840.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) Primary condition - [Peritoneal neoplasm](https://trialight.com/data/condition/peritoneal-neoplasm-14314225-1e03-5104-8c94-2081f0705b55.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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