Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.

Official Title

A Phase I Multicenter, Open Label Study of Enadenotucirev Combined With PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

Details

To characterise the safety and tolerability of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumours.

A dose escalation phase is conducted in subjects with solid tumors of epithelial origin not responding to standard therapy to establish the MTD/MFD and optimum dosing schedule of the enadenotucirev and nivolumab combination treatment.

A dose expansion phase will further outline the dose level and schedule of enadenotucirev and nivolumab combination treatment and investigate signals of efficacy in three cohorts of subjects with specific epithelial tumour types.

Keywords

Colorectal Cancer Squamous Cell Carcinoma of the Head and Neck Epithelial Tumor metastatic; epithelial; advanced Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Nivolumab enadenotucirev enadenotucirev and nivolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult males or females aged 18 years or over
  • Disease status:
  • Diagnosis of metastatic or advanced CRC, UCC and SCCHN not responding to standard therapy or for whom no standard treatment exists
  • Prior palliative radiotherapy completed at least 3 weeks before study treatment administration
  • ECOG performance status 0 or 1
  • Predicted life expectancy of 3 months or more
  • Ability to comply with study procedures in the Investigator's opinion
  • Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
  • Non-impaired renal function
  • Adequate hepatic function
  • Adequate bone marrow function:
  • Adequate coagulation tests: international normalized ratio (INR) ≤1.5
  • Meeting reproductive status requirements
  • Subjects must provide written informed consent to participate
  • Willing to consent to tumor biopsies during the study
  • Serum complement (C3/C4 proteins) above the lower limit of normal range

You CAN'T join if...

  • Pregnant or breastfeeding females
  • Known history or evidence of significant immunodeficiency due to underlying illness
  • Splenectomy
  • Prior allogeneic or autologous bone marrow or organ transplantation
  • Any history of renal disease, renal injury or auto-immune disease.
  • History of idiopathic pulmonary fibrosis, drug induced pneumonitis, evidence of active pneumonia or pneumonitis on computed tomography scan
  • Active infections requiring antibiotics, physician monitoring or recurrent fevers >100.4˚F (38.0˚C) associated with a clinical diagnosis of active infection
  • Active viral disease or positive test for hepatitis B virus using hepatitis B surface antigen test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid or HCV antibody test indicating acute or chronic infection. Positive test for HIV or AIDS; testing is not required in the absence of history
  • Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment
  • Prior treatment with PD-1 and programmed death ligand (PD-L)1 inhibitors
  • Administration of an investigational drug in the 28 days before the first dose of study treatment
  • Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational therapy in the 28 days before the first dose of study treatment
  • Other prior malignancy active within the previous 2 years except for local or organ confined early stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety
  • Symptomatic brain metastases or any leptomeningeal metastasis that is symptomatic and/or requires treatment. Subjects with brain metastases are eligible if these have been locally treated (surgery, radiotherapy).
  • Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration.
  • Known allergy to enadenotucirev, nivolumab or their excipients
  • Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  • Dependence on continuous supplemental oxygen use
  • History of myocardial infarction or significant cardiovascular or cerebrovascular event in the 12 months before the first dose of study treatment

Locations

  • UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360 accepting new patients
    Santa Monica California 90095 United States
  • City of Hope Comprehensive Cancer Center, 1500 E Duarte Str. accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PsiOxus Therapeutics Ltd
ID
NCT02636036
Phase
Phase 1
Study Type
Interventional
Last Updated