AzTrials
AzTrials

Colorectal CancerPhase 1NCT02718430

VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis

A Phase 1 study testing VXM01 in people with Colorectal Cancer, run by Vaximm GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase I study in patients with metastatic colorectal cancer with liver metastasis under second or third line therapy to examine safety, efficacy, and immune biomarkers after treatment with VXM01 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
VXM01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteGermany
Study dates
Feb 2016to Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent, including liver metastasis biopsy, signed and dated
  • Histologically or cytologically confirmed colorectal cancer, excluding primary tumors of appendiceal origin (participants are eligible to enroll irrespective of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status)
  • Male or female patients who must be post-menopausal for at least 2 years or surgically sterile.
  • Confirmed metastatic colorectal cancer (Stage IV)
  • Presence of non-resectable liver metastasis
  • Accessibility of liver metastasis appropriate for biopsy sampling
Show all 25Show fewer
  • Adequate coagulation parameters including platelet count ≥100,000/mm3
  • Absence of concomitant medication which could represent a contraindication for biopsy (e.g., anti-platelet drugs including aspirin, ticlopidine, clopidogrel, IIb/IIIa receptor antagonists, non-steroidal anti-inflammatory drugs [NSAIDs], and vitamin K antagonist anticoagulants)
  • The participant has received first-line irinotecan- or oxaliplatin-based therapy without or in combination with a targeted antibody for metastatic disease and a) Experienced radiographic disease progression during first-line therapy, or b) Experienced radiographic disease progression ≤ 6 months after the last dose of first-line therapy, or c) Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression ≤ 6 months after the last dose of first-line therapy
  • Receipt of no more than 3 prior systemic therapy regimen for metastatic disease
  • Measurable or non-measurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy > 3 months
  • Adequate renal, hepatic, and bone marrow function
  • Leukocytes ≥4.0 x 109 / L
  • Absolute neutrophil count (ANC) > 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9 g/dL (can be post-transfusion)
  • International normalized ratio (INR) ≤ 1.5
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • ALT and AST ≤ 2.5 times ULN
  • Creatinine ≤ 2.0 mg/dL
  • Proteinuria ≤ 1+ by urine dipstick OR ≤ 1 g by 24-hour urine collection
  • Patients who are able to understand the nature and purpose of the study including possible risks, willing to comply with the requirements, and to provide their written informed consent to participate in the study

Who cannot join

  • Concomitant treatment with anti-angiogenic therapy before progression of disease
  • Treatment in any other clinical trial within 30 days before screening.
  • Gastric bypass
  • Ileostoma
  • Other anatomical change of the gastrointestinal tract, interfering with gastrointestinal passage, except colostoma or colon bypass
  • Untreated CNS metastases. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment Magnetic Resonance Imaging (MRI) or intravenous (IV) contrast CT scan
Show all 34Show fewer
  • Significant traumatic injury or surgery within the past 4 weeks
  • Cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • Other malignancies within the past 5 years except for adequately treated carcinoma in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial carcinoma
  • Pre-existing sensory or motor neuropathy ≥ grade 2
  • History or evidence of CNS disease (e.g., uncontrolled seizures) by neurological examination unless adequately treated with standard medical therapy
  • History or evidence of thrombotic or hemorrhagic disorders, including intracranial hemorrhage
  • Uncontrolled hypertension (i.e., blood pressure > 160/100 mm Hg)
  • Clinically significant cardiovascular disease, including any of the following:
  • Myocardial infarction or unstable angina within the past 6 months
  • New York Heart Association class III-IV congestive heart failure
  • Poorly controlled cardiac arrhythmia despite medication, except rate controlled atrial fibrillation
  • Peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision)
  • Positive for anti-typhoid IgG/IgM antibodies according to the onsite test on Day 0
  • Hemoptysis within 6 months before randomization
  • Esophageal varices
  • Upper or lower gastrointestinal bleeding within 6 months before randomization
  • Non-healing wound, incomplete wound healing, bone fracture or any history of gastrointestinal ulcers within three years before inclusion, or positive gastroscopy within 3 months before inclusion
  • Gastrointestinal fistula
  • Thrombolysis therapy within 4 weeks before randomization
  • Presence of any acute or chronic systemic infection
  • Major surgical procedures, or open biopsy within 4 weeks before randomization
  • Chronic concurrent therapy within 2 weeks before and during the initial treatment period (Day 1 to Day 7):
  • Corticosteroids (except steroids for adrenal failure or emesis prophylaxis up to 4 mg daily dose) or immunosuppressive agents
  • Antibiotics
  • Bevacizumab or any other anti-angiogenic treatment
  • Known multi-drug resistant gram-negative bacteria
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the study results or render the patient at high risk for treatment complications
  • Women of childbearing potential

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • National Center of Tumor Diseases

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis Under Second or Third Line Therapy to Examine Safety, Efficacy, and Immune Biomarkers After Treatment With VXM01

Phase I study in patients with metastatic colorectal cancer with liver metastasis under second or third line therapy to examine safety, efficacy, and immune biomarkers after treatment with VXM01

Being tested
VXM01
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VXM01Drug

    Oral immunotherapy targeting VEGFR2

Study groups in NCT02718430
Study groupRoleWhat they receive
VXM01ExperimentalVXM01 10E6 or 10E7 CFU
Receives: Drug: VXM01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability taking into account treatment-limiting toxicities (TLTs)

    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.

    Measured: 18 months

Secondary outcomes (6)

  1. Immune Response by Enzme Linked Immuno Spot (ELISpot)

    Patient-individual VEGFR-2 specific T-cell responses determined by ELISpot using cryopreserved peripheral blood mononuclear cells (PBMC)

    Measured: 18 months

  2. Immune biomarker by tumor tissue immunohistochemistry staining

    Immune biomarker including T-cell infiltration, Treg, myeloid derived suppressor cells (MDSC) by tumor tissue immunohistochemistry staining

    Measured: 66 days

  3. Tumor vasculature by tumor tissue immunohistochemistry staining

    Measured: 66 days

  4. Serum biomarker Response by Enzyme Linked Immuno Sorbent Assay (ELISA)

    Serum VEGF A and collagen IV measured by ELISA

    Measured: 18 months

  5. Clinical Response including tumor staging according to the response criteria in solid tumors (RECIST)

    Tumor staging according to the response criteria in solid tumors (RECIST) and investigation of the primary tumor and metastasis, e.g., determination of primary tumor size, number and size of metastasis.

    Measured: 18 months

  6. Biodistribution and shedding of VXM01

    Bacterial vector tissue biodistribution, persistence, and shedding of viable Ty21a bacteria (VXM01) determined by cultivation of stool samples

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718430
Sponsor's protocol ID
VXM01-03-DE
Status last verified
May 2018
First submitted
16 Mar 2016
Last updated
19 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VXM01 in people with Colorectal Cancer, run by Vaximm GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability taking into account treatment-limiting toxicities (TLTs) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02718430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in