GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    20
  • sponsor
    Genexine, Inc.
Updated on 25 March 2022

Summary

The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

Description

This is a phase 2 study designed to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

A total of 20 patients will be enrolled in the study and administered bevacizumab GX-I7. The study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.

Details
Condition Recurrent Glioblastoma
Treatment bevacizumab, GX-I7
Clinical Study IdentifierNCT05191784
SponsorGenexine, Inc.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 19 years
Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
Karnofsky Performance Status; KPS ≥ 60
Life expectancy > 12 weeks
Adequate hematologic and end organ function

Exclusion Criteria

Malignancies other than disease under study within 5 years prior to the first dose of study drug
Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
Body Mass Index (BMI) ≥ 30 kg/m2
Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
Clinically significant cardiovascular disease
History of arterial or venous thromboembolism 6 months prior to study participation
Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)
History of hypertensive crisis or hypertensive encephalopathy
Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
Pregnancy or breastfeeding
Subjects with active virus infection
Subjects with autoimmune disease/ syndromes
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia
Prior allogeneic bone marrow transplantation or prior solid organ transplantation
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note