A Study of ARGX-110 in Participants With Advanced Malignancies

Neoplasms Clinical Trial

Official title:

A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813539
• Other study ID #: CR108755
• Secondary ID: ARGX-110-1201201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 27, 2013
• Est. completion date: July 10, 2020

Study information

• Verified date: August 2023
• Source: OncoVerity, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• ARGX-110
ARGX-110 will be administered as an IV infusion.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
OncoVerity, Inc.	argenx, Janssen Research & Development, LLC

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicity (DLT)	DLT is defined as drug-related grade 3 or 4 clinical adverse event (AE) occurring during the 21 days (3 weeks) following the first dose of ARGX-110.	21 days
Secondary	Plasma Concentrations of ARGX-110	Plasma concentration of ARGX-110 will be assessed.	Up to 2 years
Secondary	Biomarkers (CD70 qPCR and sCD27) of ARGX-110 biological activity	Biomarkers (CD70 quantitative polymerase chain reaction [CD70 qPCR] and soluble CD27 [sCD27]) will be measured in serum and on tumor samples to correlate systemic drug effects with AE and Tumor response.	Up to 2 years
Secondary	Number of Participants who Achieve a Tumor Response	Tumor response will be assessed according to RECIST.	Up to 2 years