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| ID | Type | Description | Link |
|---|---|---|---|
| ARGX-110-1201 | Other Identifier | Janssen Research & Development, LLC | |
| 2012-005046-38 | EudraCT Number |
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| Name | Class |
|---|---|
| argenx | INDUSTRY |
| Janssen Research & Development, LLC | INDUSTRY |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: Cohort 1 | Experimental | Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1. |
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| Dose Escalation: Cohort 2 | Experimental | Participants will receive ARGX-110 as an IV infusion at dose level 2. |
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| Dose Escalation: Cohort 3 | Experimental | Participants will receive ARGX-110 as an IV infusion at dose level 3. |
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| Dose Escalation: Cohort 4 | Experimental | Participants will receive ARGX-110 as an IV infusion at dose level 4. |
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| 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. |
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| Safety Expansion: Cohort 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARGX-110 | Drug | ARGX-110 will be administered as an IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of ARGX-110 | Plasma concentration of ARGX-110 will be assessed. | Up to 2 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24492296 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Up to 2 years |
| Number of Participants who Achieve a Tumor Response | Tumor response will be assessed according to RECIST. | Up to 2 years |
| Edegem |
| Belgium |
| Ghent | Belgium |
| Bordeaux | France |
| Lille | France |
| Paris | France |
| Pierre-Bénite | France |
| Villejuif | France |