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Clinical Trials in the UK / NCT06003231
Active, not recruiting Phase 2

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

NCT06003231 · tracked via the Priya Life Science UK tracker
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Phase
Phase 2
Started
2023-11-14
Last updated
2026-07-22

Condition(s) studied

Carcinoma, Non-Small-Cell LungOvarian NeoplasmsEndometrial NeoplasmsHead and Neck Neoplasms

Investigational drug(s) / intervention(s)

disitamab vedotin

disitamab vedotin: Given into the vein (IV, intravenous) every 2 weeks

Study summary

This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, participants must have tumors that have a marker called HER2.

This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks.

This study is being done to see if DV works to treat different types of solid tumors that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Cohort 1: Head and neck cancer (HNC) * Must have pathologically-documented carcinoma of the head and neck with primary tumor site arising from the oral cavity, salivary gland, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded. * Unresectable locally recurrent or metastatic stage disease * Prior therapies: * Participants must have disease progression after treatment with a platinum-based therapy * Cohort 2: Non-small cell lung cancer (NSCLC) * Pathologically documented NSCLC * Unresectable locally-advanced or metastatic stage disease * Prior therapies * Must have progressed during or after a platinum-based therapy for LA/metastatic disease or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease * Must have received prior anti-PD(L)1 therapy, unless contraindicated * Participants with known AGAs must have received appropriate targeted therapy, where available. * No more than 2 prior lines of cytotoxic chemotherapy for advanced disease * Cohort 3: Ovarian Cancer * Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin * Unresectable locally-advanced or metastatic stage disease * Prior therapies * Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence) * Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease * Participants with known BRCA mutations are permitted, but participants must have received targeted therapy with a PARP inhibitor * May have received prior anti-PD(L)1 therapy * Cohort 4: Endometrial Cancer * Must have pathologically documented adenocarcinoma of the endometrium * Must have unresectable locally-advanced or metastatic stage disease. * Prior therapies * Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease * Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease * May have received prior anti-PD(L)1 therapy * HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue. Note: Participants with HER2 mutations are eligible. * Measurable disease per RECIST v1.1 criteria as assessed by the investigator * Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Prior treatment with an MMAE-containing agent. * Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin. * History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. * Active untreated CNS or leptomeningeal metastasis

Primary outcome measure(s)

Trial sites (96)

FacilityCityRegionStatus
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Chandler Arizona
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Gilbert Arizona
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Glendale Arizona
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Mesa Arizona
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Mesa Arizona
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Phoenix Arizona
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Scottsdale Arizona
Valkyrie Clinical Trials(Additional Suite) Los Angeles California
Valkyrie Clinical Trials Los Angeles California
University of California Davis Comprehenvise Cancer Center Sacramento California
University of California Davis Medical Center Sacramento California
Providence Medical Foundation Santa Rosa California
PCM Trails Denver Colorado
PCM Trials Denver Colorado
Smilow Cancer Hospital at Yale - New Haven New Haven Connecticut
Yale-New Haven Hospital-Yale Cancer Center New Haven Connecticut
Smilow Cancer Hospital Phase 1 Unit New Haven Connecticut
Yale Cancer Center New Haven Connecticut
Smilow Cancer Hospital Care Center at Trumbull Trumbull Connecticut
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center Coral Gables Florida
University of Miami Hospital and Clinics Deerfield Beach Deerfield Beach Florida
Sylvester Comprehensive Cancer Center Miami Florida
University of Miami Hospital and Clinics Miami Florida
Sylvester Comprehensive Cancer Center - Kendall Miami Florida
Sylvester Comprehensive Cancer Center Plantation Plantation Florida
Georgia Cancer Center at Augusta University Augusta Georgia
Wellstar MCG Health Clinical Research Pharmacy Augusta Georgia
Brigham and Women's Hospital (BWH) Boston Massachusetts
Dana-Farber Cancer Institute (DFCI) Boston Massachusetts
Dana-Farber Cancer Institute - Chestnut Hill Newton Massachusetts
Karmanos Cancer Institute Detroit Michigan
Karmanos Cancer Institute Weisberg Cancer Treatment Center Farmington Hills Michigan
Minnesota Oncology Hematology, P.A. Burnsville Minnesota
Allina Health Cancer institute Coon Rapids Minnesota
Minnesota Oncology Hematology, P.A. Coon Rapids Minnesota
M Health Fairview Cancer Clinic-Edina Edina Minnesota
Minnesota Oncology Hematology, P.A. Edina Minnesota
Minnesota Oncology Hematology, P.A. Fridley Minnesota
Minnesota Oncology Hematology, P.A. Maple Grove Minnesota
M Health Fairview St. John's Hospital Maplewood Minnesota

+ 56 more sites — see the full list on the official registry below.

More Seagen, a wholly owned subsidiary of Pfizer trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06003231 on ClinicalTrials.gov ↗ ← All trials in the UK