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A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
EU CTIS ID: 2023-504445-31-00
What this study is testing
To evaluate the antitumor activity of disitamab vedotin in participants with previously treated, locally-advanced unresectable or metastatic (LA/m) HER2 expressing solid tumors
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cohort 1: 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 or other first line treatment regimen
- Cohort 2: NSCLC •Pathologically documented NSCLC •Unresectable locally-advanced or metastatic stage disease •Prior therapies: -Must have progressed during or after a platinum-based therapy 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 -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: Subjects with HER2 mutations are eligible.
- Measurable disease per RECIST v1.1 criteria as assessed by the investigator.
You likely can't join 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
See the full eligibility criteria
Who can join
- Cohort 1: 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 or other first line treatment regimen
- Cohort 2: NSCLC •Pathologically documented NSCLC •Unresectable locally-advanced or metastatic stage disease •Prior therapies: -Must have progressed during or after a platinum-based therapy 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 -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: Subjects 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.
What rules you out
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United States
- Canada
- Japan
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United States; Canada; Japan; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.