PhIb/II Open-Label Study Disitamab Vedotin Monother or inCombination w/OtherAntica Therapies SolidTu

UCI Specialty Area: Cancer

Principal Investigator: Farshid Dayyani

Official Title: A Phase Ib/II Open-Label Study of Disitamab Vedotin Monotherapy or in Combination with Other Anticancer Therapies in Solid Tumors

A Study On:

Breast

Esophagus

Stomach

Study Description

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.

Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.

This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them.

This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®.

This study will test how safe and how well DV, with or without tucatinib, is for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Eligibility

-Measurable disease according to RECIST v1.1

-Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

-Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma

-Locally-advanced, unresectable, or metastatic stage

-You must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.

-Histologically or cytologically confirmed diagnosis of breast carcinoma

-Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib

-Prior therapy with ADCs with MMAE payload

-Prior therapy with tucatinib

-Active CNS and/or leptomeningeal metastasis.

-Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment

-History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.

-Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

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