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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Natrunix (vilamakitug)
i
Other names: XB2001
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News alerts, weekly reports and conference planners
Company:
XBiotech
Drug class:
IL-1α inhibitor
Related drugs:
6ms
TASKIN: Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1α True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine (clinicaltrials.gov)
P1/2, N=160, Active, not recruiting, Centre Georges Francois Leclerc | Recruiting --> Active, not recruiting
Enrollment closed
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
|
oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • Natrunix (vilamakitug)
8ms
Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment (clinicaltrials.gov)
P2, N=108, Not yet recruiting, XBiotech, Inc. | Trial completion date: May 2025 --> Mar 2026 | Initiation date: Sep 2024 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jan 2026
Trial completion date • Trial initiation date • Trial primary completion date
|
Natrunix (vilamakitug)
9ms
1-BETTER: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=76, Active, not recruiting, XBiotech, Inc. | Completed --> Active, not recruiting | Trial completion date: Jun 2024 --> Jun 2025
Enrollment closed • Trial completion date
|
5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Natrunix (vilamakitug)
11ms
Safety and efficacy of trifluridine/tipiracil +/- bevacizumab plus XB2001 (anti-IL-1α antibody): a single-center phase 1 trial. (PubMed, Signal Transduct Target Ther)
XB2001, a fully human monoclonal antibody neutralizing IL-1α, was evaluated for safety and preliminary efficacy with trifluridine/tipiracil (FTD/TPI) and bevacizumab in metastatic colorectal cancer patients previously treated with oxaliplatin- and irinotecan-based chemotherapies. High intratumoral IL-1α expression at baseline and CD8/PD-L1 infiltration are associated with a better progression-free survival. The combination of XB2001 with FTD/TPI and bevacizumab is feasible and safe, and showed encouraging clinical activity in chemotherapy-resistant mCRC.
P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6)
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CD8 expression
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Avastin (bevacizumab) • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • Natrunix (vilamakitug)
11ms
Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis (clinicaltrials.gov)
P2, N=243, Completed, XBiotech, Inc. | Recruiting --> Completed
Trial completion
|
Natrunix (vilamakitug)
1year
Natrunix in Combination with Methotrexate for Rheumatoid Arthritis Treatment (clinicaltrials.gov)
P2, N=108, Not yet recruiting, XBiotech, Inc.
New P2 trial • Combination therapy
|
Natrunix (vilamakitug)
over1year
Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis (clinicaltrials.gov)
P2, N=60, Not yet recruiting, XBiotech, Inc.
New P2 trial • Combination therapy
|
Natrunix (vilamakitug)
over1year
1-BETTER: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=76, Completed, XBiotech, Inc. | Active, not recruiting --> Completed | Trial primary completion date: Feb 2024 --> Oct 2023
Trial completion • Trial primary completion date • Combination therapy • Metastases
|
5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Natrunix (vilamakitug)
almost2years
TASKIN: Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1α True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine (clinicaltrials.gov)
P1/2, N=160, Recruiting, Centre Georges Francois Leclerc | Not yet recruiting --> Recruiting | Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Mar 2024 --> Oct 2026
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
|
oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • Natrunix (vilamakitug)
almost2years
Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis (clinicaltrials.gov)
P2, N=210, Recruiting, XBiotech, Inc. | Not yet recruiting --> Recruiting | N=150 --> 210 | Trial completion date: Feb 2023 --> Aug 2024 | Trial primary completion date: Dec 2022 --> Jun 2024
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
Natrunix (vilamakitug)
2years
1-BETTER: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=69, Active, not recruiting, XBiotech, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> May 2024 | Trial primary completion date: Jul 2023 --> Feb 2024
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Natrunix (vilamakitug)
over3years
1-BETTER: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=69, Recruiting, XBiotech, Inc. | Trial completion date: Oct 2022 --> Aug 2023 | Trial primary completion date: Apr 2022 --> Jul 2023
Trial completion date • Trial primary completion date • Combination therapy
|
CD14 (CD14 Molecule)
|
5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Natrunix (vilamakitug)
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