Skip to main content
OpenTrials
Completed

NCT Number: NCT01813539

A Study of ARGX-110 in Participants With Advanced Malignancies

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brussels, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARGX-110

Drug

ARGX-110 will be administered as an IV infusion.

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicity (DLT)

    Time frame: 21 days

    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.

Secondary outcomes

  1. Plasma Concentrations of ARGX-110

    Time frame: Up to 2 years

    Plasma concentration of ARGX-110 will be assessed.

  2. Biomarkers (CD70 qPCR and sCD27) of ARGX-110 biological activity

    Time frame: Up to 2 years

    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.

  3. Number of Participants who Achieve a Tumor Response

    Time frame: Up to 2 years

    Tumor response will be assessed according to RECIST.

Sponsors and collaborators

Lead sponsor

OncoVerity, Inc.

Industry

Collaborators

  • Janssen Research & Development, LLC
  • argenx

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2013
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.