Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Phase I: XB2001 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumor V1.1 * Documented disease progression after one pri...
Top 20 of 68 competitors
XB2001 is an investigational monoclonal antibody being studied for the treatment of pancreatic cancer. It is being evaluated in combination with ONIVYDE plus 5-FU/LV (folinic acid) in patients with advanced pancreatic cancer. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
XB2001 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential role in treating pancreatic cancer, though the precise mechanism of action is not publicly detailed in the current development data.
XB2001 is being developed by XBiotech Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XBIT. The company is conducting clinical research on this investigational monoclonal antibody for pancreatic cancer, with the drug currently in Phase 1 development.
XB2001 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for safety and efficacy in patients with advanced pancreatic cancer, and its clinical development program is still in the early stages.
XB2001 has one completed clinical trial registered under NCT04825288, titled "XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer." This Phase 1 study enrolled 76 participants in the United States and was a randomized, double-blind, controlled trial involving adult patients of all sexes.