Trials / Terminated
TerminatedNCT06120504
A Safety Study of PF-08046045/SGN-35T in Adults With Advanced Cancers
An Open-label Phase 1 Study to Evaluate the Safety of PF-08046045/SGN-35T in Adults With Advanced Malignancies
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infections. There are several types of lymphoma. This study will enroll people who have lymphoma, such as classical Hodgkin lymphoma, peripheral T-cell lymphoma including systemic anaplastic large cell lymphoma, diffuse large B-cell lymphoma, or some types of primary cutaneous lymphoma. This clinical trial uses a drug called PF-08046045/SGN-35T. The study drug is in testing and has not been approved for sale. This is the first time PF-08046045 will be used in people. The study drug will be given as an infusion through a vein. This study will test the safety of PF-08046045 in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for PF-08046045. Part C will use the dose found in parts A and B to find out how safe PF-08046045 is and if it works to treat select lymphomas.
Detailed description
This is a phase 1, open-label, multicenter study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-08046045/SGN-35T in adults with select relapsed/refractory lymphomas. PF-08046045 is a CD30-directed antibody-drug conjugate and will be studied in patients with lymphomas expressing CD30.
Conditions
- Lymphoma, T-Cell, Cutaneous
- Hodgkin Disease
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-08046045 | Given into the vein (IV; intravenously) |
Timeline
- Start date
- 2024-02-29
- Primary completion
- 2025-12-10
- Completion
- 2025-12-10
- First posted
- 2023-11-07
- Last updated
- 2026-01-26
Locations
17 sites across 2 countries: United States, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06120504. Inclusion in this directory is not an endorsement.