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

NCT02718430 | Completed Phase 1 DMC

• 1 other identifier: VXM01-03-DE
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (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.

  18 months

Secondary Outcomes (6)

• Immune Response by Enzme Linked Immuno Spot (ELISpot)

  18 months

• Immune biomarker by tumor tissue immunohistochemistry staining

  66 days

• Tumor vasculature by tumor tissue immunohistochemistry staining

  66 days

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

  18 months

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

  18 months

Study Arms (1)

VXM01

EXPERIMENTAL

VXM01 10E6 or 10E7 CFU

Drug: VXM01

Interventions

VXM01 DRUG

Oral immunotherapy targeting VEGFR2

VXM01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vaximm GmbH: lead

Study Sites (1)

National Center of Tumor Diseases

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Carsten Gruellich, MD

  National Center of Tumor Diseases Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 24, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)