A Study of ARGX-110 in Participants With Advanced Malignancies

OncoVerity

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neoplasms

Treatments: Drug: ARGX-110

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813539

2012-005046-38 (EudraCT Number)

ARGX-110-1201 (Other Identifier)

CR108755

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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99 participants in 10 patient groups

Dose Escalation: Cohort 1

Experimental group

Description:

Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1.

Treatment:

Drug: ARGX-110

Dose Escalation: Cohort 2

Experimental group

Description:

Participants will receive ARGX-110 as an IV infusion at dose level 2.

Treatment:

Drug: ARGX-110

Dose Escalation: Cohort 3

Experimental group

Description:

Participants will receive ARGX-110 as an IV infusion at dose level 3.

Treatment:

Drug: ARGX-110

Dose Escalation: Cohort 4

Experimental group

Description:

Participants will receive ARGX-110 as an IV infusion at dose level 4.

Treatment:

Drug: ARGX-110

Dose Escalation: Cohort 5

Experimental group

Description:

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.

Treatment:

Drug: ARGX-110

Safety Expansion: Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: ARGX-110

Safety Expansion: Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: ARGX-110

Safety Expansion: Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: ARGX-110

Safety Expansion: Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: ARGX-110

Exploratory Efficacy: Cohort 5

Experimental group

Description:

Participants with relapsed/refractory CTCL will receive ARGX-110 as an IV infusion followed by a maintenance therapy at dose level 3.

Treatment:

Drug: ARGX-110