NCT01813539

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

7.4 years

First QC Date

March 7, 2013

Last Update Submit

August 7, 2023

Conditions

Neoplasms

Keywords

Malignancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Plasma Concentrations of ARGX-110

    Up to 2 years

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

    Up to 2 years

  • Number of Participants who Achieve a Tumor Response

    Up to 2 years

Study Arms (10)

Dose Escalation: Cohort 1

EXPERIMENTAL

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

Drug: ARGX-110

Dose Escalation: Cohort 2

EXPERIMENTAL

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

Drug: ARGX-110

Dose Escalation: Cohort 3

EXPERIMENTAL

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

Drug: ARGX-110

Dose Escalation: Cohort 4

EXPERIMENTAL

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

Drug: ARGX-110

Dose Escalation: Cohort 5

EXPERIMENTAL

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.

Drug: ARGX-110

Safety Expansion: Cohort 1

EXPERIMENTAL

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.

Drug: ARGX-110

Safety Expansion: Cohort 2

EXPERIMENTAL

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.

Drug: ARGX-110

Safety Expansion: Cohort 3

EXPERIMENTAL

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.

Drug: ARGX-110

Safety Expansion: Cohort 4

EXPERIMENTAL

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.

Drug: ARGX-110

Exploratory Efficacy: Cohort 5

EXPERIMENTAL

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

Drug: ARGX-110

Interventions

ARGX-110DRUG

ARGX-110 will be administered as an IV infusion.

Dose Escalation: Cohort 1Dose Escalation: Cohort 2Dose Escalation: Cohort 3Dose Escalation: Cohort 4Dose Escalation: Cohort 5Exploratory Efficacy: Cohort 5Safety Expansion: Cohort 1Safety Expansion: Cohort 2Safety Expansion: Cohort 3Safety Expansion: Cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Edegem, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Villejuif, France

Location

Related Publications (1)

  • Silence K, Dreier T, Moshir M, Ulrichts P, Gabriels SM, Saunders M, Wajant H, Brouckaert P, Huyghe L, Van Hauwermeiren T, Thibault A, De Haard HJ. ARGX-110, a highly potent antibody targeting CD70, eliminates tumors via both enhanced ADCC and immune checkpoint blockade. MAbs. 2014 Mar-Apr;6(2):523-32. doi: 10.4161/mabs.27398. Epub 2013 Dec 6.

    PMID: 24492296DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 19, 2013

Study Start

February 27, 2013

Primary Completion

July 10, 2020

Study Completion

July 10, 2020

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

BE(3)FR(5)