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2021-01-18
2024-03-01
2024-03-01
111
NCT04665921
Seagen Inc.
Seagen Inc.
INTERVENTIONAL
A Study of SGN-STNV in Advanced Solid Tumors
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 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 dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-12-07 | N/A | 2025-02-06 |
2020-12-07 | N/A | 2025-02-07 |
2020-12-14 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: SGN-STNV SGN-STNV monotherapy | DRUG: SGN-STNV
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | To be summarized using descriptive statistics | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Incidence of laboratory abnormalities | To be summarized using descriptive statistics | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Incidence of dose limiting toxicities | To be summarized using descriptive statistics | Up to 28 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 | ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR). | Up to approximately 3 years |
| Progression-free survival (PFS) | PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first. | Up to approximately 3 years |
| Overall survival (OS) | OS is defined as the time from the start of any study treatment to the date of death due to any cause. | Up to approximately 3 years |
| Duration of objective response (DOR) | DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first. | Up to approximately 3 years |
| Area under the concentration-time curve (AUC) | Pharmacokinetic (PK) endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Time to maximum concentration (Tmax) | PK endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Maximum concentration (Cmax) | PK endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Trough concentration (Ctrough) | PK endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Incidence of antidrug antibodies (ADA) | Immunogenicity endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
