A Study of ARGX-110 in Participants With Advanced Malignancies

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01813539
• Collaborator: argenx (Industry)
• Enrollment: 99
• Locations: 8
• Arms: 10
• Actual Duration (Months): 88.4
• Patients Per Site: 12.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Feb 27, 2013
• Actual Primary Completion Date: Jul 10, 2020
• Actual Study Completion Date: Jul 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Dose Limiting Toxicity (DLT) [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 [Up to 2 years]

   Plasma concentration of ARGX-110 will be assessed.

2. Biomarkers (CD70 qPCR and sCD27) of ARGX-110 biological activity [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 [Up to 2 years]

   Tumor response will be assessed according to RECIST.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Brussel		Belgium
2		Edegem		Belgium
3		Gent		Belgium
4		Bordeaux		France
5		Lille		France
6		Paris		France
7		Pierre-Bénite		France
8		Villejuif		France

Sponsors and Collaborators

• Janssen Research & Development, LLC
• argenx

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01813539
• Other Study ID Numbers: CR108755; ARGX-110-1201; 2012-005046-38
• First Posted: Mar 19, 2013
• Last Update Posted: Aug 6, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janssen Research & Development, LLC: Malignancy
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Aug 6, 2021