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Also known as vilamakitug, Natrunix
XB2001 · 4 trials · 6 indications
ASAS40 response is defined at least a 40% improvement in at least three of the four main ASAS domains, with no worsening in the remaining domain: Patient Global Assessment of Disease Activity (Q3 of ASDAS-CRP), Pain Assessment (BASDAI Q2), physical function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and Inflammation (represented by the mean of the two morning stiffness BASDAI questions Q5 and Q6).
The American College of Rheumatology (ACR) response criteria for rheumatoid arthritis (RA) are used to measure how effective study drug is in this study.
The ACR is a measure used in clinical practice and clinical trial to assess medication efficacy in patients with RA, by notating improvements in swelling and tenderness in designated joints, as well as improvements in at least 3 out of 5 other categories. The other categories assessed are patient global assessment of disease activity, physician global assessment of disease activity, patient reported pain scale, disability/functionality questionnaire response, and acute phase reactant levels (CRP and ESR).
The primary objective of the Phase I portion is to identify the MTD of XB2001 when administered in combination with ONIVYDE + LV + 5-FU. The MTD is defined as the highest dose level at which no more than one out of six subjects experience a DLT. If two or more subjects in a cohort of six experience a DLT, the MTD is considered exceeded, and the previous lower dose level will be identified as the MTD. If no DLTs are observed at the highest dose level studied, that dose will be used for Phase II. A DLT is defined as any Grade 3-4 adverse event (per NCI CTCAE v5.0) occurring within the first 28 days that is deemed possibly related to the combination regimen, unless the toxicity is clearly attributable to a single non-XB2001 component. Specific DLT criteria include: 1. Inability to deliver all scheduled doses during the 28-day window due to unexpected drug-related toxicity. 2. Inability to deliver the intended dose of XB2001 due to drug-related toxicity.
This endpoint evaluates the cumulative safety profile and patient tolerance of XB2001 when administered at the Maximum Tolerated Dose (MTD) or the maximum dose studied in Phase I, in combination with the ONIVYDE + LV + 5-FU regimen. Safety is characterized by the total number of participants in each cohort who experienced one or more adverse events. For the purpose of this count, each participant is counted only once, regardless of the total number of individual adverse events experienced.
| Arm | Type | Description |
|---|---|---|
| vilamakitug | EXPERIMENTAL | weekly dose of vilamakitug |
| placebo | PLACEBO_COMPARATOR | placebo |
| 400mg Natrunix + MTX weekly | EXPERIMENTAL | Subjects will receive 400mg Natrunix and MTX weekly |
| Placebo+ MTX weekly | EXPERIMENTAL | Subjects will receive placebo and MTX weekly |
| Natrunix 200mg with MTX(+Folate) | EXPERIMENTAL | Natrunix 200mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects. |
| Natrunix 400mg with MTX(+Folate) | EXPERIMENTAL | Natrunix 400mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects. |
| Placebo with MTX(+Folate) | PLACEBO_COMPARATOR | Placebo in combination with Methotrexate (+Folate).This arm will enroll 70 subjects. |
| Phase I: Dose Escalation Phase | EXPERIMENTAL | In Phase I (Dose escalation phase), 3 sequential dose levels were administered by participants; 250 mg (dose cohort 1), 500 mg (dose cohort 2), and 1000 mg (dose cohort 3), and traditional 3:3 design was used. Dose-escalation will continue if none of three subjects experience a dose-limiting toxicity (DLT). After enrollment participants received two treatment cycles (a total of 28 days) in which they were given one intravenous (IV) dose of XB2001 prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. |
| Phase II: Dose Expansion Phase | EXPERIMENTAL | In Phase II (dose expansion phase), participants were randomized in 1:1 fashion and received: 1. XB2001 1000 mg combination with ONIVYDE, Leucovorin, and 5-Fluorouracil 2. Placebo 1000 mg in combination with ONIVYDE, Leucovorin, and 5-Fluorouracil |
| Name | Type | Description |
|---|---|---|
| vilamakitug | DRUG | Vilamakitug is a monoclonal antibody preparation, indistinguishable from a natural antibody isolated from a healthy human. |
| placebo | DRUG | placebo |
| Natrunix 400 mg | BIOLOGICAL | The active ingredient of Natrunix is an IgG4 monoclonal antibody indistinguishable from that naturally occurring in an IL-1a-immune healthy human. Natrunix is formulated as 200 mg/mL sterile liquid in a stabilizing isotonic formulation buffered to pH 7.0. The product is filled into a 2 mL glass pre-filled syringe suitable for subcutaneous injection. The drug product is formulated and buffered to a neutral body pH of 7.0. |
| Methotrexate (MTX) | DRUG | Methotrexate may be administered in pill form by mouth, as liquid by mouth, or by subcutaneous injection.Subjects enrolled in this study should be receiving a stable minimum weekly dose of 10mg. Weekly methotrexate should not exceed 25 mg/week. |
| Natrunix | DRUG | Natrunix is a unique kind of drug-an immunoglobulin cloned from a naturally occurring immune response from a healthy human donor. Natrunix blocks inflammation in a unique way-it is the only therapeutic that exclusively neutralizes interleukin-1α (IL-1α), a crucial mediator of interleukin-1 inflammation. Targeting IL-1α directly using a natural human monoclonal antibody may provide a safer and more effective means of blocking interleukin-1 in rheumatoid arthritis. |
| Phase I: XB2001 250 mg | BIOLOGICAL | Subjects were administered one intravenous (IV) dose of XB2001 250 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. |
| Phase I: XB2001 500 mg | BIOLOGICAL | Subjects were administered one intravenous (IV) dose of XB2001 500 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. |
| Phase I: XB2001 1000 mg | BIOLOGICAL | Subjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. |
| Phase II: XB2001 1000 mg | BIOLOGICAL | Subjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. |
| Phase II: Placebo | BIOLOGICAL | Subjects were administered one intravenous (IV) dose of placebo 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle. |
Inclusion Criteria: 1. Male or female aged ≥18 and ≤65 years, with body weight \>40 kg at screening, who are willing to provide informed consent, attend all clinic visits, comply with study-related procedures and able to understand and complete study-related questionnaires. 2. Must meet the ASAS-SP...
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XB2001 is being developed for the treatment of pancreatic cancer. It is an investigational monoclonal antibody studied in patients with advanced pancreatic cancer, specifically in combination with the chemotherapy regimen ONIVYDE plus 5-FU/LV with folinic acid. XB2001 has completed a Phase 1 clinical trial and is not approved for any indication.
XB2001 is being developed by XBiotech Inc., which trades on the Nasdaq under the ticker symbol XBIT. The company sponsored the Phase 1 trial of XB2001 in advanced pancreatic cancer conducted in the United States.
XB2001 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 76 patients and evaluated XB2001 in combination with ONIVYDE plus 5-FU/LV with folinic acid in advanced pancreatic cancer.
XB2001 has been evaluated in one clinical trial, NCT04825288, titled "XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer." This Phase 1 trial was completed, enrolled 76 participants, and was conducted in the United States in patients with pancreatic cancer.