Clinical trial · Interventional
A Study of ARGX-110 in Participants With Advanced Malignancies
A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.
NCT01813539CI-TRIAL-00068702completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARGX-110 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Dose Escalation: Cohort 1
- description
- Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1.
- interventionNames
- Drug: ARGX-110
- type
- EXPERIMENTAL
- label
- Dose Escalation: Cohort 2
- description
- Participants will receive ARGX-110 as an IV infusion at dose level 2.
- interventionNames
- Drug: ARGX-110
- type
- EXPERIMENTAL
- label
- Dose Escalation: Cohort 3
- description
- Participants will receive ARGX-110 as an IV infusion at dose level 3.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSilence 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 24492296