Status:
COMPLETED
A Study of ARGX-110 in Participants With Advanced Malignancies
Lead Sponsor:
OncoVerity, Inc.
Collaborating Sponsors:
argenx
Janssen Research & Development, LLC
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).
Detailed Description
Phase I study conducted in participants whose tumors express the target of interest. Pharmacokinetics (PK), pharmacodynamics (PD), biomarkers will be determined to support dose selection. Phase II st...
Eligibility Criteria
Inclusion
- Histological diagnosis of malignancy refractory to, or relapsing after standard therapy
- Solid tumors or T-cell malignancies positive for the CD70 antigen by Immunohistochemistry/Fluorescence-activated cell sorting (IHC/FACS) within 56 days prior to administering the first dose of ARGX-110. IHC criterion: greater than \> 10 percent (%) of CD70 positive tumor cells
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or 2
- Serum albumin greater than or equal to (\>=) 20 gram per liter (g/L) (solid tumor only)
- Ability to comply with protocol-specified procedures/evaluations and scheduled visits. In particular, the ability of the patient to undergo a tumor biopsy (optional for safety expansion cohort 4)
Exclusion
- History or clinical evidence of neoplastic central nervous system (CNS) involvement
- History of another primary malignancy that has not been in remission for at least 1 year
- Systemic glucocorticoid administration at doses greater than physiological replacement (prednisolone 20 milligram \[mg\] equivalent) within 28 days of ARGX-110 first dose administration (for T-cell malignancies higher systemic dose can be allowed following discussion with Sponsor)
- Major surgery within 28 days of ARGX-110 first dose administration
- Unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy
Key Trial Info
Start Date :
February 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2020
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01813539
Start Date
February 27 2013
End Date
July 10 2020
Last Update
August 9 2023
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Brussels, Belgium
2
Edegem, Belgium
3
Ghent, Belgium
4
Bordeaux, France