Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06157892
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-11-27
Brief Title:
A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase 1b2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 theyve grown bigger in one spot or spread to other parts of the body theyre 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
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
Detailed Description:
This clinical trial is to evaluate disitamab vedotin alone and in combination with tucatinib in subjects with LAmetastatic breast cancer or gastric cancerGEJC 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 LAmBC subjects Once the safety and efficacy profile of disitamab vedotin plus tucatinib has been established and a disitamab vedotin dose with the optimum benefitrisk 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 mGCGEJC and HER2 LAmBC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None