Trials / Completed
CompletedNCT02432235
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma
A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients With Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- ADC Therapeutics S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates camidanlumab tesirine in participants with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma.
Detailed description
This is a Phase I, first in human clinical study with camidanlumab tesirine to evaluate the safety and tolerability and pharmacokinetics of camidanlumab tesirine in participants with relapsed/refractory lymphoma. Camidanlumab tesirine is a human monoclonal antibody attached via a cleavable linker to a pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells, covalently cross links deoxyribonucleic acid (DNA) preventing replication. The study will be conducted in 2 parts: Part 1 (dose escalation) and Part 2 (expansion).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Camidanlumab tesirine | Intravenous (IV) infusion. |
Timeline
- Start date
- 2015-10-05
- Primary completion
- 2019-10-24
- Completion
- 2019-10-24
- First posted
- 2015-05-04
- Last updated
- 2021-07-13
- Results posted
- 2021-07-13
Locations
12 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT02432235. Inclusion in this directory is not an endorsement.