Title
A Study of ARGX-110 in Participants With Advanced Malignancies
A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.
Phase
Phase 1Lead Sponsor
argenxStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
NeoplasmsIntervention/Treatment
cusatuzumab ...Study Participants
99The 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).
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 study conducted in Cutaneous T-cell lymphoma (CTCL) participants who are CD70 positive. PK, PD, biomarkers and immunohistochemistry (IHC) will be determined to assess efficacy.
ARGX-110 will be administered as an IV infusion.
Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1.
Participants will receive ARGX-110 as an IV infusion at dose level 2.
Participants will receive ARGX-110 as an IV infusion at dose level 3.
Participants will receive ARGX-110 as an IV infusion at dose level 4.
Participants will receive ARGX-110 as an IV infusion at intermediate dose level at the conclusion of Cohort 4 prior to opening the safety expansion cohorts to participants enrolment.
Participants with solid tumors will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
Participants with cutaneous T-cell lymphoma (CTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
Participants with hematological malignancies (all etiologies) will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
Participants with peripheral T-cell lymphoma (PTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
Participants with relapsed/refractory CTCL will receive ARGX-110 as an IV infusion followed by a maintenance therapy at dose level 3.
Inclusion Criteria: 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 Criteria: 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
