Trials / Terminated
TerminatedNCT04665921
A Study of SGN-STNV in Advanced Solid Tumors
A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 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.
Conditions
- Carcinoma, Non-Small Cell Lung
- HER2 Negative Breast Neoplasms
- Ovarian Neoplasms
- Uterine Cervical Neoplasms
- Endometrial Neoplasms
- Esophageal Neoplasms
- Gastroesophageal Junction Carcinoma
- Stomach Neoplasms
- Colorectal Neoplasms
- Exocrine Pancreatic Adenocarcinoma
- Appendiceal Adenocarcinoma
- Pseudomyxoma Peritonei
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SGN-STNV | Given into the vein (IV; intravenously) |
Timeline
- Start date
- 2021-01-18
- Primary completion
- 2024-03-01
- Completion
- 2024-03-01
- First posted
- 2020-12-14
- Last updated
- 2025-02-07
Locations
18 sites across 6 countries: United States, Canada, France, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04665921. Inclusion in this directory is not an endorsement.