Share
Save
A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors
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.
Study details:
This clinical trial is to evaluate disitamab vedotin alone and in combination with tucatinib in subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by a dose optimization phase. The 2 dose levels identified in the dose escalation phase will be assessed in the optimization phase for both safety and efficacy in HER2-low LA/mBC subjects.
Once the safety and efficacy profile of disitamab vedotin plus tucatinib has been established and a disitamab vedotin dose with the optimum benefit/risk ratio has been determined the disitamab vedotin plus tucatinib combination therapy will be evaluated in an expansion phase with 2 expansion cohorts in subjects with HER2 low mGC/GEJC and HER2 + LA/mBC.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-05-20
Primary completion: 2030-01-31
Study completion finish: 2030-01-31
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06157892
Intervention or treatment
DRUG: disitamab vedotin
DRUG: tucatinib
Conditions
- • Gastroesophageal Junction Adenocarcinoma
- • Metastatic Breast Cancer
- • Breast Neoplasms
- • HER2 Low Breast Neoplasms
- • HER2 Positive Breast Neoplasms
- • Stomach Neoplasms
- • Triple Negative Breast Neoplasms
- • Metastatic Gastric Cancer
- • Advanced Breast Cancer
- • Advanced Gastric Cancer
Find a site
Closest Location:
Peninsula and South East Oncology
Research sites nearby
Select from list below to view details:
Peninsula and South East Oncology
Frankston, Other, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Escalation - Previously treated advanced GC/GEJC or breast cancer
| DRUG: disitamab vedotin
|
EXPERIMENTAL: Cohort A monotherapy - HER2-low 2L or 3L breast cancer
| DRUG: disitamab vedotin
|
EXPERIMENTAL: Cohort A - HER2-low 2L or 3L breast cancer
| DRUG: disitamab vedotin
|
EXPERIMENTAL: Cohort B monotherapy - HER2+ 3L or higher breast cancer
| DRUG: disitamab vedotin
|
EXPERIMENTAL: Cohort B - HER2+ 3L or higher breast cancer
| DRUG: disitamab vedotin
|
EXPERIMENTAL: Cohort C monotherapy - HER2-low 2L GC/GEJC
| DRUG: disitamab vedotin
|
EXPERIMENTAL: Cohort C - HER2-low 2L GC/GEJC
| DRUG: disitamab vedotin
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with dose limiting toxicities DLTs) in dose escalation phase | Not Specified | Up to 28 days |
Number of participants with adverse events (AEs) | 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 | Through 30 days after the last study treatment; approximately 5 years |
Number of participants with laboratory abnormalities | Not Specified | Through 30-37 days after the last study treatment: approximately 5 years |
Number of participants with dose alterations | Not Specified | 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 | The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1. | Approximately 3 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Duration of response (DOR) per RECIST v1.1 by investigator assessment | The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause | Approximately 5 years |
Disease control rate (DCR) per RECIST v1.1 by investigator assessment | The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1. | Approximately 5 years |
Progression free survival (PFS) per RECIST v1.1 by investigator assessment | The time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the first documentation of disease progression per RECIST v1.1 or death due to any cause. | Approximately 5 years |
Overall survival (OS) | The time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the date of death due to any cause. | Approximately 5 years |
Pharmacokinetic (PK) parameter - Maximum concentration (Cmax) | Not Specified | Through 30-37 days after the last study treatment; approximately 5 years |
PK parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast) | Not Specified | Approximately 1 month |
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin | Not Specified | Through 30-37 days after the last study treatment; approximately 5 years |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!