Trials / Terminated
TerminatedNCT05194072
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
A Phase 1 Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease. This study is seeking for participants who either have cancer: * that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable), * has spread through the body (metastatic), or have some cancer left over after surgery. This study will have five parts. * Parts A and B of the study will find out how much Felmetatug Vedotin should be given to participants. * Part C will use the amount found in Parts A and B to find out how safe Felmetatug Vedotin is and if it works to treat solid tumor cancers. * Part D will find out if and how much Felmetatug Vedotin can be given with pembrolizumab. * Part E will use the amount found in Part D to find out how safe Felmetatug Vedotin with pembrolizumab is and if it works to treat triple negative breast cancer.
Conditions
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
- Triple Negative Breast Neoplasms
- HER2 Negative Breast Neoplasms
- Hormone Receptor Positive Breast Neoplasms
- Endometrial Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Cholangiocarcinoma
- Gallbladder Carcinoma
- Adenoid Cystic Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Felmetatug Vedotin | Given into the vein (IV; intravenously) |
| DRUG | Pembrolizumab | 400 mg every 6 weeks, given by IV |
Timeline
- Start date
- 2022-01-12
- Primary completion
- 2025-05-14
- Completion
- 2025-05-14
- First posted
- 2022-01-18
- Last updated
- 2026-01-09
Locations
27 sites across 5 countries: United States, Canada, Germany, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05194072. Inclusion in this directory is not an endorsement.