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

Running, not enrolling · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Endometrial Neoplasms, Head and Neck Neoplasms

In brief

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.

Key facts

Study ID: NCT06003231
Run by: Seagen, a wholly owned subsidiary of Pfizer
People needed: 120
Starts: 2023-11-14
Expected to finish: 2028-05-31
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Gilbert, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Glendale, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Mesa, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Mesa, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Phoenix, Arizona, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Scottsdale, Arizona, United States
Valkyrie Clinical Trials(Additional Suite) — Los Angeles, California, United States
Valkyrie Clinical Trials — Los Angeles, California, United States
University of California Davis Comprehenvise Cancer Center — Sacramento, California, United States
University of California Davis Medical Center — Sacramento, California, United States
Providence Medical Foundation — Santa Rosa, California, United States
PCM Trails — Denver, Colorado, United States
PCM Trials — Denver, Colorado, United States
Smilow Cancer Hospital at Yale - New Haven — New Haven, Connecticut, United States
Yale-New Haven Hospital-Yale Cancer Center — New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
Yale Cancer Center — New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Trumbull — Trumbull, Connecticut, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center — Coral Gables, Florida, United States
University of Miami Hospital and Clinics Deerfield Beach — Deerfield Beach, Florida, United States
Sylvester Comprehensive Cancer Center — Miami, Florida, United States
University of Miami Hospital and Clinics — Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Kendall — Miami, Florida, United States
Sylvester Comprehensive Cancer Center Plantation — Plantation, Florida, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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