A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
disitamab vedotin: Given into the vein (IV; intravenous)
tucatinib: 300mg given twice daily by mouth (orally)
Study summary
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 tucatinib works 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
Primary outcome measure(s)
- Number of participants with dose limiting toxicities (DLTs) in dose escalation phase — Up to 28 days
- Number of participants with adverse events (AEs) — Through 30 days after the last study treatment; approximately 5 years
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention - Number of participants with laboratory abnormalities — Through 30-37 days after the last study treatment: approximately 5 years
- Number of participants with dose alterations — Through 30-37 days after the last study treatment: approximately 5 years
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment — Approximately 3 years
The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.
Trial sites (135)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner-University Medical Center Tucson Campus | Tucson | Arizona | |
| Banner-University Medical Center Tucson Campus | Tucson | Arizona | |
| The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal | Tucson | Arizona | |
| University of Arizona Cancer Center - North Campus | Tucson | Arizona | |
| The University of Arizona Cancer Center-Main | Tucson | Arizona | |
| UC Irvine Health - Chao Family Comprehensive Cancer Center | Orange | California | |
| UC Irvine Medical Center | Orange | California | |
| University of California, San Francisco | HDFCCC - Hematopoietic Malignancies | San Francisco | California | |
| UCLA Department of Medicine - Hematology & Oncology | Santa Monica | California | |
| UCLA Hematology/Oncology - Parkside | Santa Monica | California | |
| Colorado West Healthcare System, dba Community Hospital | Grand Junction | Colorado | |
| Colorado West Healthcare, dba Grand Valley Oncology | Grand Junction | Colorado | |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | |
| Moffitt Cancer Center - International Plaza | Tampa | Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | |
| Moffitt McKinley Hospital | Tampa | Florida | |
| Moffitt Cancer Center at Wesley Chapel | Wesley Chapel | Florida | |
| Georgia Cancer Specialists - Athens | Athens | Georgia | |
| Georgia Cancer Specialists - Annex | Atlanta | Georgia | |
| Atlanta Cancer Care - Atlanta | Atlanta | Georgia | |
| Georgia Cancer Specialists-Northside | Atlanta | Georgia | |
| Northside Hospital, Inc.- Central Research Department | Atlanta | Georgia | |
| Northside Hospital | Atlanta | Georgia | |
| Georgia Cancer Specialists - Blairsville | Blairsville | Georgia | |
| Georgia Cancer Specialists - Canton | Canton | Georgia | |
| Atlanta Cancer Care - Cumming | Cumming | Georgia | |
| Georgia Cancer Specialists - Cumming | Cumming | Georgia | |
| Georgia Cancer Specialists - Decatur | Decatur | Georgia | |
| Suburban Hematology-Oncology Associates - Duluth | Duluth | Georgia | |
| Suburban Hematology-Oncology Associates- Lawrenceville | Lawrenceville | Georgia | |
| Georgia Cancer Specialists - Macon | Macon | Georgia | |
| Georgia Cancer Specialists - Marietta | Marietta | Georgia | |
| Memorial Hospital | Shiloh | Illinois | |
| Siteman Cancer Center - Shiloh | Shiloh | Illinois | |
| Massachusetts General Hospital. | Boston | Massachusetts | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Dana Farber Cancer Institute- Chestnut Hill | Newton | Massachusetts |
+ 95 more sites — see the full list on the official registry below.
More Seagen, a wholly owned subsidiary of Pfizer trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06157892 on ClinicalTrials.gov ↗ ← All trials in Italy