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A Study of ARGX-110 in Participants With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01813539
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : August 6, 2021
Sponsor:
Collaborator:
argenx
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Neoplasms Drug: ARGX-110 Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.
Actual Study Start Date : February 27, 2013
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020

Arm Intervention/treatment
Experimental: Dose Escalation: Cohort 1
Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1.
Drug: ARGX-110
ARGX-110 will be administered as an IV infusion.

Experimental: Dose Escalation: Cohort 2
Participants will receive ARGX-110 as an IV infusion at dose level 2.
Drug: ARGX-110
ARGX-110 will be administered as an IV infusion.

Experimental: Dose Escalation: Cohort 3
Participants will receive ARGX-110 as an IV infusion at dose level 3.
Drug: ARGX-110
ARGX-110 will be administered as an IV infusion.

Experimental: Dose Escalation: Cohort 4
Participants will receive ARGX-110 as an IV infusion at dose level 4.
Drug: ARGX-110
ARGX-110 will be administered as an IV infusion.

Experimental: Dose Escalation: Cohort 5
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
ARGX-110 will be administered as an IV infusion.

Experimental: Safety Expansion: Cohort 1
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
ARGX-110 will be administered as an IV infusion.

Experimental: Safety Expansion: Cohort 2
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
ARGX-110 will be administered as an IV infusion.

Experimental: Safety Expansion: Cohort 3
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
ARGX-110 will be administered as an IV infusion.

Experimental: Safety Expansion: Cohort 4
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
ARGX-110 will be administered as an IV infusion.

Experimental: Exploratory Efficacy: Cohort 5
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
ARGX-110 will be administered as an IV infusion.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813539


Locations
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Belgium
Brussel, Belgium
Edegem, Belgium
Gent, Belgium
France
Bordeaux, France
Lille, France
Paris, France
Pierre-Bénite, France
Villejuif, France
Sponsors and Collaborators
Janssen Research & Development, LLC
argenx
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01813539    
Other Study ID Numbers: CR108755
ARGX-110-1201 ( Other Identifier: Janssen Research & Development, LLC )
2012-005046-38 ( EudraCT Number )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Malignancy
Additional relevant MeSH terms:
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Neoplasms