BridgeMD
New treatment option for Breast Cancer
Official title A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
ClinicalTrials.gov ID: NCT06966453
What this study is testing
What is Disitamab vedotin?
Disitamab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as RC48, RC48-ADC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer). This study is seeking participants who: have breast cancer that is hard to treat and has spread in the body (advanced cancer) have tumors that have HER2 on them have received previous treatment for their advanced breast cancer All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma.
- Human epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) status appropriate for enrollment in cohort.
- HER2 status determined by most recent local assessment based on American Society of Clinical Oncology (ASCO) and College of American Pathologists...
- HER2+: immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridization (ISH)+
- HER2-low: IHC 1+/ISH-negative or untested or IHC 2+/ISH-negative
You likely can't join if
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
- Active central nervous system (CNS) and/or leptomeningeal metastasis.
- Participants with a history of other invasive malignancy within 3 years before the Cycle 1 Day 1 (C1D1) of study intervention, or any evidence of...
- Prior therapy with ADCs with MMAE payload.
- Participants who have received prior systemic anticancer treatment or radiotherapy within 2 weeks, or 5 half-lives, whichever is shorter, prior to...
- Participants must have recovered from all adverse events due to previous therapies.
See the full eligibility criteria
- Histologically or cytologically confirmed diagnosis of locally-advanced, unresectable, or metastatic breast carcinoma.
- Human epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) status appropriate for enrollment in cohort.
- HER2 status determined by most recent local assessment based on American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) guidelines for assessment of HER2 in BC for interpretation of HER2...
- HER2+: immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridization (ISH)+
- HER2-low: IHC 1+/ISH-negative or untested or IHC 2+/ISH-negative
- HER2-ultralow: IHC 0 with membrane staining (any staining of the membrane in \>0 and ≤10% of cancer cells) o HR+ disease is determined as either estrogen receptor (ER) and/or progesterone receptor (PgR) positive [ER or...
- Received prior trastuzumab, pertuzumab and a taxane if available as local first line standard of care therapy for advanced disease.
- Prior tucatinib based therapy is allowed.
- Must have progression on or after, or be intolerant to, T-DXd in any line advanced disease setting.
- No more than 3 prior systemic cytotoxic therapy regimens (including antibody drug conjugates [ADCs]) for Locally Advanced (LA)/metastatic breast cancer (mBC). Participants previously treated with (neo)adjuvant cytotoxic...
- No more than 3 prior systemic cytotoxic therapy regimens (including ADCs) for LA/mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of cytotoxic treatment...
- Participants with known germline breast cancer gene (BRCA) mutation must have received a poly-ADP ribose polymerase (PARP) inhibitor, where available and not medically contraindicated.
- Must have progression on or after, or be intolerant to, trastuzumab deruxtecan (T-DXd) in any line advanced disease setting.
- Must have intolerance to endocrine therapy (ET) or ET refractory disease:
- Progressed on ≥2 lines of ET for LA/mBC AND had received a cyclin-dependent kinase (CDK)4/6 inhibitor in the adjuvant or metastatic setting if available as local standard of care and not contraindicated. OR
- Progressed on 1 line of ET for LA/mBC AND had a relapse while on adjuvant ET after definitive surgery for primary tumor AND had received a cyclin-dependent kinase (CDK) 4/6 inhibitor in the adjuvant or advanced setting...
- No more than 4 prior systemic cytotoxic chemotherapy regimens (including ADCs) for advanced or mBC. Participants previously treated with (neo)adjuvant cytotoxic therapy and have disease relapsed within 6 months of...
- Known germline BRCA mutation must have received a PARP-inhibitor if available as local standard of care therapy and not medically contraindicated.
- Prior sacituzumab govitecan is allowed.
- Prior T-DXd is allowed.
- Participants with HR negative (TNBC), HER2-low and programmed cell death receptor ligand 1 (PD-L1)-positive (combined positive score [CPS] ≥10) tumors must have received pembrolizumab (or other PD-L1 inhibitor) with...
- Participants with HR+/HER2-ultra low tumors must have received at least 1 antihormonal therapy in any setting or be ineligible for ET.
- Participants with HR+/HER2-ultra low tumors must have had prior therapy with a CDK4/6 inhibitor in the adjuvant or advanced setting.
- Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
- Active central nervous system (CNS) and/or leptomeningeal metastasis.
- Participants with a history of other invasive malignancy within 3 years before the Cycle 1 Day 1 (C1D1) of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Prior therapy with ADCs with MMAE payload.
- Participants who have received prior systemic anticancer treatment or radiotherapy within 2 weeks, or 5 half-lives, whichever is shorter, prior to C1D1 of study intervention. Note: If the last immediate anticancer...
- Participants must have recovered from all adverse events due to previous therapies.
The study team makes the final eligibility decision.
Where it's taking place
- Daphne, Alabama, United States
- Foley, Alabama, United States
- Mobile, Alabama, United States
- Gilbert, Arizona, United States
- Anaheim, California, United States
- Duarte, California, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Stanford, California, United States
- Van Nuys, California, United States
- Aurora, Colorado, United States
- Boulder, Colorado, United States
- Centennial, Colorado, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Englewood, Colorado, United States
- Lakewood, Colorado, United States
+ 119 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daphne, Alabama, United States; Foley, Alabama, United States; Mobile, Alabama, United States; Gilbert, Arizona, United States; Anaheim, California, United States; Duarte, California, United States and 133 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.