Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665921
Status:
TERMINATED
Last Update Posted:
2024-03-19
First Post:
2020-12-07
Brief Title:
A Study of SGN-STNV in Advanced Solid Tumors
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to portfolio prioritization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors It will study SGN-STNV to find out what its side effects are A side effect is anything the drug does besides treating cancer It will also study how well SGN-STNV works to treat solid tumors
The study will have two parts Part A of the study will find out how much SGN-STNV should be given to patients Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors
The study will have two parts Part A of the study will find out how much SGN-STNV should be given to patients Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors
Detailed Description:
The study will include dose escalation Part A and dose expansion Part B with multiple disease-specific cohorts and a biology cohort in dose expansion The biology cohort will require additional biopsies At the completion of dose escalation up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee SMC Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A The doses to be examined in Part B will be at or below the maximum tolerated dose andor the recommended dose determined in Part A The recommended dose andor schedule may differ between cohorts
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