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Phase I Study of Safety and Immunogenicity of ADU-623

NCT01967758 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-08-17

No results posted yet for this study

Summary

This is a study for patients with brain tumors called astrocytic tumors. The study will enroll patients who have received standard treatment. The study will test a vaccine called ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if ADU-623 can be given safely to brain cancer patients and what is the better dose to give patients among the three doses that planned to be tested. This study will also evaluate the length of time before patients' cancer worsens and if ADU-623 helps patients to live longer. The study will also measure the body's immune system response to ADU-623.

Conditions

Interventions

BIOLOGICAL

Cohort 1

Four doses of IV ADU-623 at a dose of 3 x 10\^7cfu

BIOLOGICAL

Cohort 2

Four doses of IV ADU-623 at a dose of 3 x 10\^8cfu

BIOLOGICAL

Cohort 3

Four doses of IV ADU-623 at a dose of 3 x 10\^9cfu

DRUG

Antibiotics

A 3-day course of oral amoxicillin (500 mg three times per day) or trimethoprim/sulfamethoxazole in penicillin-allergic patients (160 mg trimethoprim / 800mg sulfamethoxazole at 12 hour intervals) will be initiated for each patient 3 days following each dose of ADU-623. Patients will receive a 7-day course of antibiotics starting at the end of treatment visit.

Sponsors & Collaborators

  • Aduro Biotech, Inc.

    collaborator INDUSTRY

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Marka Crittenden, MD, PhD · Providence Health & Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-08
Primary Completion
2018-06-18
Completion
2018-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01967758 on ClinicalTrials.gov