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VXM01

Phase 1

Colorectal Cancer | Small molecule | Oncology |OSR Holdings, Inc.|Last Updated: Oct 19, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

VXM01 · 3 trials · 3 indications

Phase 1 3
NCT02718443VXM01 Phase I Pilot Study in Patients With Operable Recurrence of a GlioblastomaGlioblastoma
COMPLETED14 Analytics
NCT02718430VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver MetastasisColorectal Cancer
COMPLETED6 Analytics
NCT01486329VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic CancerStage IV Pancreatic Cancer
COMPLETED72 Analytics
PHASE1COMPLETED
VXM01 Phase I Pilot Study in Patients With Operable Recurrence of a Glioblastoma
GlioblastomaUnlock trial analytics
PHASE1COMPLETED
VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis
Colorectal CancerUnlock trial analytics
PHASE1COMPLETED
VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer
Stage IV Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability taking into account treatment-limiting toxicities (TLTs)
12 months

AEs listed together with information on onset, duration, severity, seriousness, relationship to the study drug, relationship to chemotherapy and to the underlying disease, outcome, and action taken. Frequency tables by System Organ Class and preferred term.

Safety and tolerability
38 days

Number of dose-limiting toxicities and maximum tolerated dose

Secondary Endpoints

Immune Response by Enzyme Linked Immuno Spot (ELISpot)
12 months
Serum biomarker Response by Enzyme Linked Immuno Sorbent Assay (ELISA)
12 months
Vascular normalization index (VNI) including tumor perfusion acc. to Sorensen 2009
12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VXM01EXPERIMENTALVXM01 10E6 or 10E7 CFU
PlaceboPLACEBO_COMPARATORPlacebo control

Interventions

NameTypeDescription
VXM01DRUGOral immunotherapy targeting VEGFR2
PlaceboBIOLOGICALDrink solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Written informed consent, signed and dated 2. Histologically diagnosed intracranial supratentorial malignant glioma (contrast-enhancing anaplastic astrocytoma WHO Grade III or glioblastoma WHO Grade IV). 3. Male or female patients who must be post-menopausal for at least 2 ye...

Countries:Germany
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Competitive Landscape -Colorectal Cancer 257 trials

Frequently asked questions about VXM01

What is VXM01 used for?

VXM01 is an investigational small molecule being studied for the treatment of Stage IV pancreatic cancer, colorectal cancer, and glioblastoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing VXM01?

VXM01 is being developed by OSR Holdings, Inc., a company publicly traded under the ticker symbol OSRH. The company is conducting clinical trials for this investigational oncology drug.

What phase is VXM01 in?

VXM01 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. All completed trials for VXM01 are Phase 1 studies.

What clinical trials is VXM01 in?

VXM01 has been studied in three completed Phase 1 trials: NCT01486329 in Stage IV pancreatic cancer, NCT02718430 in metastatic colorectal cancer with liver metastasis, and NCT02718443 in operable recurrence of glioblastoma. These trials were conducted in Germany.

Is VXM01 the same as any other drug?

VXM01 is the primary name for this investigational drug. No alternative names have been reported for this asset in the available clinical trial information.