Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARGX-110 · 3 trials · 4 indications
DLTs will be defined as any of the following drug-related events: Any grade 3 or higher drug related non-hematological toxicity or; Grade 3 or higher IRRs or; inability to administer the next dose due to a drug-related adverse event or a delay of the administration of the next dose due to toxicities for more than 14 days despite adequate medication or; drug-related grade 4 febrile neutropenia or; drug-related grade 4 anemia which cannot be adequately treated.
ORR is defined as the sum of Complete remission (CR), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR) at the ARGX-110 RP2D level that was established in Phase 1 according to established response criteria for Acute myeloid leukemia (AML).
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.
Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03
| Arm | Type | Description |
|---|---|---|
| ARGX-110 with Azacytidine (AZA) | EXPERIMENTAL | Phase 1: Participants will receive loading dose of ARGX-110 1 milligram per kilogram (mg/kg) body weight (cohort 1), 3 mg/kg body weight (cohort 2), 10 mg/kg body weight (cohort 3) or 20 mg/kg body weight (cohort 4) administered intravenously (IV) in combination with AZA standard dose of 75 milligram per meter square (mg/m\^2) body surface area (BSA) administered subcutaneously (SC) / intravenously (IV). Phase 2: Participants will receive loading dose of ARGX-110 IV at a recommended dose for Phase 2 (RP2D) level from phase 1 in combination with AZA standard dose of 75 mg/m\^2 BSA, administered SC/IV as per local practice. |
| Dose Escalation: Cohort 1 | EXPERIMENTAL | Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1. |
| Dose Escalation: Cohort 2 | EXPERIMENTAL | Participants will receive ARGX-110 as an IV infusion at dose level 2. |
| Dose Escalation: Cohort 3 | EXPERIMENTAL | Participants will receive ARGX-110 as an IV infusion at dose level 3. |
| Dose Escalation: Cohort 4 | EXPERIMENTAL | Participants will receive ARGX-110 as an IV infusion at dose level 4. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| adjuvant monotherapy | EXPERIMENTAL | ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles |
| metastatic/recurrent monotherapy | EXPERIMENTAL | ARGX-110 5mg/kg once every three weeks until disease progression |
| metastatic/recurrent combination therapy | EXPERIMENTAL | ARGX-110 5mg/kg once every three weeks plus chemotherapy until disease progression. The choice of the chemotherapy agents is limited to: cisplatin, carboplatin, 5-fluorouracil, gemcitabine and paclitaxel. |
| Name | Type | Description |
|---|---|---|
| ARGX-110 | DRUG | ARGX-110 will be administered intravenously. |
| AZA | DRUG | AZA will be administered subcutaneously/intravenously. |
Inclusion Criteria: * Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study * Acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) (according to 2016 Wo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
ARGX-110 is an investigational small molecule being studied for the treatment of cancer, including acute myeloid leukemia and other neoplasms. It has been evaluated in clinical trials for advanced malignancies, nasopharyngeal carcinoma, and in combination with azacytidine for newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndromes.
ARGX-110 is being developed by argenx SE, a biopharmaceutical company listed on the stock exchange under the ticker ARGX. The company has sponsored clinical trials of ARGX-110 in oncology indications.
ARGX-110 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for ARGX-110 were Phase 1 studies.
ARGX-110 has been studied in three completed Phase 1 trials: NCT01813539 in participants with advanced malignancies, NCT02759250 in patients with nasopharyngeal carcinoma, and NCT03030612 in combination with azacytidine for newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndromes.
ARGX-110 is also known by the name cusatuzumab. It is a monoclonal antibody that targets CD70, a protein involved in tumor growth and immune evasion.