A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 (NCT06003231) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
United States, Australia, Canada120 participantsStarted 2023-11-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 r…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for tumors that express HER2 — can you test my tumor to find out whether it expresses HER2 at a level that would even be relevant to a study like this?
2Since this trial is in Phase 2, what do we know so far about the safety profile of Disitamab Vedotin, and what side effects should I be aware of when weighing it against my current options?
3The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — are there any other ongoing or upcoming trials studying Disitamab Vedotin or similar HER2-targeted therapies that I might still be able to join?
4This study is measuring objective response rate, meaning how many patients' tumors shrink — based on what's been seen in similar trials so far, how does that compare to what standard treatments might offer for my specific cancer type?
5Given that my cancer is one of the types included in this trial — such as non-small-cell lung, ovarian, endometrial, or head and neck — would you recommend pursuing a HER2-targeted approach at this stage, or is there a standard second-line treatment I should try first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Timeframe: Approximately 3 years
Trial details
NCT IDNCT06003231
SponsorSeagen, a wholly owned subsidiary of Pfizer